<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293342</url>
  </required_header>
  <id_info>
    <org_study_id>REC-2017/97</org_study_id>
    <nct_id>NCT03293342</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioural Therapy and Dental Fear</brief_title>
  <official_title>The Effect of a Dentist Administered Cognitive Behavioural Therapy (D-CBT) in Adult Patients With Dental Fear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is an RCT study comparing a 3-5 intervention treatment with dentist administered&#xD;
      Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a&#xD;
      &quot;treatment as usual&quot; concept using premedication with benzodiazepines and a common sense&#xD;
      approach.&#xD;
&#xD;
      The treatment will be performed in a regular dental office. The dentist is working as a&#xD;
      regular dentist and is trained in the CBT Method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brief Summary:&#xD;
&#xD;
      The study is an randomized clinical trial (RCT) comparing a 3-5 intervention treatment with&#xD;
      dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The&#xD;
      control treatment is a &quot;treatment as usual&quot; concept using premedication with benzodiazepines&#xD;
      and a common sense approach.&#xD;
&#xD;
      The treatment will be performed in a regular dental office. The dentist is working as a&#xD;
      regular dentist and is trained in the CBT Method.&#xD;
&#xD;
      Detailed Description:&#xD;
&#xD;
      Background Dental fear is common in adults and has a prevalence of about 10-25%.&#xD;
      Approximately 2/3 of fearful patients manage to get through treatment, but with great&#xD;
      discomfort. The remaining 1/3 avoid dental visits and some of them qualify for the diagnosis&#xD;
      odontophobia (prevalence 1,4-7,1%).&#xD;
&#xD;
      Several studies demonstrate reduced oral health in people with dental fear and odontophobia&#xD;
      compared to the general population.&#xD;
&#xD;
      Dental phobia often develops gradually and patients' dental health would often benefit from&#xD;
      treatment of dental anxiety before the manifestations of phobia; before dental health&#xD;
      deteriorate and avoidance of dental treatment has lasted too long.&#xD;
&#xD;
      Consequently, it would be beneficial if dental anxiety were effectively treated in a dentist&#xD;
      general practice and thereby easily accessible. Thus there is a need for evidence based&#xD;
      treatment methods for this context.&#xD;
&#xD;
      Psychological treatment of dental phobia is well documented in multidisciplinary treatment&#xD;
      programmes were psychologists and dentists work together. However, there is a lack of&#xD;
      psychologist resources and high cost of a treatment approach that requires 2 specialists.&#xD;
      This emphasises the need for treatment programs of dental anxiety within dentist's&#xD;
      competence. Dentists can, provided the right training, be successful in the utilisation of&#xD;
      psychological techniques for the treatment of anxiety. Willumsen et al developed and tested&#xD;
      dental anxiety treatment methods including the use of CBT interventions for use by dentists.&#xD;
      This RCT study showed good results at post treatment, also in a 5 year follow up. Two CBT&#xD;
      methods (applied relaxation and cognitive therapy) with contrasting principles (relaxation vs&#xD;
      activation) were tested against nitrous oxide sedation. All three treatment approaches showed&#xD;
      adequate effect but CBT interventions were superior in a longer time perspective. However,&#xD;
      the treatment methods were resource demanding; requiring 10 sessions of treatment. It would&#xD;
      therefore be beneficial to develop a shorter method of treatment that could be used by a&#xD;
      dentist in a general practice and also to test its use within the context of a regular dental&#xD;
      practice.&#xD;
&#xD;
      Premedication with benzodiazepines and a common sense approach including tell-show-do is the&#xD;
      recommended and most frequent used alternative in Norway when treating this group of patients&#xD;
      in general dental practice; Therefore the study is designed to compare the psychological&#xD;
      intervention with these treatment modalities to explore differences in effect.&#xD;
&#xD;
      The hypothesis is that a treatment programme with D-CBT have more reduction of dental fear&#xD;
      than traditional treatment with common sense/ premedication&#xD;
&#xD;
      The aims:&#xD;
&#xD;
        1. Test D-CBT against a combined pharmacological common sense approach in a RCT study&#xD;
           performed in a general dental practice.&#xD;
&#xD;
        2. To explore whether demographical data, levels of dental fear, comorbidity, coping&#xD;
           strategies or dentist-patient relation can predict treatment outcome of D-CBT.&#xD;
&#xD;
        3. To do a 1-year- and 3 year follow-up on the RCT-patients with assessment of levels of&#xD;
           dental fear in the patient, quality of life, oral quality of life and ability to receive&#xD;
           dental treatment.&#xD;
&#xD;
           Methods Design The study is a randomized controlled trial. Population Patients will be&#xD;
           recruited through written and oral information to local dentists and physicians,&#xD;
           advertising in local newspapers or referred from a waiting list at a local dental fear&#xD;
           clinic .&#xD;
&#xD;
           Criteria for inclusion&#xD;
&#xD;
             -  Strong dental anxiety that affects the patients self-perceived ability to go&#xD;
                through dental treatment&#xD;
&#xD;
             -  Age over 18&#xD;
&#xD;
             -  Agreement to all the practical arrangements of the study Criteria for exclusion&#xD;
&#xD;
             -  Substance abuse&#xD;
&#xD;
             -  Not being able to communicate fluently in Norwegian Sample size Sample size was&#xD;
                estimated with power (1-Betta) 0,8 og type error (alfa) 5%. From these criteria&#xD;
                sample size was calculated to 30 in each group. Drop out is expected to be about&#xD;
                15% giving 35 participants in each group and a total of 70 participants in the&#xD;
                RCT-study.&#xD;
&#xD;
           Location and operator The study will be performed in a general dental practice in&#xD;
           Mandal, a small town in the south of Norway. All patients will be treated by the same&#xD;
           dentist, an experienced private practitioner with an interest in treating dentally&#xD;
           anxious patients; MSH.&#xD;
&#xD;
           Research psychologists and dentists experienced in treating patients with dental fear&#xD;
           have developed the dentist-based cognitive behaviour treatment method (D-CBT). D-CBT is&#xD;
           based on existing literature.&#xD;
&#xD;
           In addition an expert group consisting of clinical psychologists and dentists, all of&#xD;
           which are experienced in treating dental anxiety, have assessed the practical aspects of&#xD;
           implementing the method and manual.&#xD;
&#xD;
           A manual describes the intervention in detail. The method will be tested in 5 patients&#xD;
           in a pilot study.&#xD;
&#xD;
           Randomisation procedure Patients are randomized in two groups by simple randomisation.&#xD;
           Lists will be constructed by statistical software and treatments will then be allocated&#xD;
           to patients in sequence using numbered opaque envelopes containing treatment&#xD;
           allocations.&#xD;
&#xD;
           The intervention group All patients in the D-CBT group will go through 3- 5&#xD;
           consultations with a duration of 60 minutes or 3 sessions of 90 minutes aimed at&#xD;
           treating their dental anxiety. The appointments will be spaced with a maximum of 2 weeks&#xD;
           to minimize the setback that will often occur between appointments (detailed description&#xD;
           in appendix).&#xD;
&#xD;
           All sessions will be videotaped throughout the study. The control group The&#xD;
           non-intervention group will be offered premedication with midazolam during dental&#xD;
           treatment per standard procedures. Common sense principles as communication skills,&#xD;
           control and tell-show-do will be implemented.&#xD;
&#xD;
           Similarities between the control and the intervention groups:&#xD;
&#xD;
             -  Building a good relation with the patient&#xD;
&#xD;
             -  Stop signal will be utilized&#xD;
&#xD;
             -  Explain and show what the dentist wants to do before doing treatment (tell-show-do)&#xD;
&#xD;
             -  The treatment should be as painless as possible&#xD;
&#xD;
           Differences between the control and the intervention groups:&#xD;
&#xD;
           Midazolam/tell-show-do&#xD;
&#xD;
             -  Sedation is an alternative&#xD;
&#xD;
             -  Minimalizing exposure to the patient (for example hiding instead of showing the&#xD;
                syringe while putting the anaesthetics).&#xD;
&#xD;
           Psycological intervention -characteristics&#xD;
&#xD;
             -  Psychoeducation about anxiety&#xD;
&#xD;
             -  Exploration of the individual anxiety&#xD;
&#xD;
             -  Exposure to the frightening stimuli (no hiding, but actively showing in detail all&#xD;
                components of dental treatment, preferably utilizing a mirror while doing&#xD;
                treatment).&#xD;
&#xD;
           Data Each patient receives a project number. A codebook between project number and&#xD;
           journal number is stored at the Specialist Center of Public Dental Health in South&#xD;
           Norway All data will be registered online using Nettskjema to collect data directly into&#xD;
           Services for sensitive data (TSD). The research data from each patient will only be&#xD;
           identified by the project number.&#xD;
&#xD;
           All data will be stored and analysed using the TSD platform. TSD complies with the&#xD;
           directive of privacy and electronic communication in Norway. TSD is developed and&#xD;
           operated by the University of Oslos' centre for IT (USIT).&#xD;
&#xD;
           Only MSH and the supervisors will be given access to the data in TSD. All video&#xD;
           recordings will be stored on encrypted memory sticks locked in a filing cabinet. The key&#xD;
           to the filing cabinet is kept in a key cabinet locked by a code. The code is known only&#xD;
           by the dentist (MSH) and the dental secretary (KL). The recordings will be stored up&#xD;
           until publication of articles and TW is responsible for deleting them.&#xD;
&#xD;
           Statistics The current project uses a traditional experimental research design to assess&#xD;
           the research hypothesis. In order to compare differences between the 35 participants in&#xD;
           the two research conditions the data will be analysed with regression analysis. A 2x2&#xD;
           repeated measures ANOVA will be used to test if the experimental condition of five&#xD;
           sessions of D-CBT treatment is superior to the control condition of premedication and&#xD;
           gradual habituation. A factor analytic approach will be used to assess the level of&#xD;
           influence on the results by factors like: age; gender; social economic status and&#xD;
           substance abuse. The statistical analysis will be completed using the IBM SPSS&#xD;
           statistical software version 16.0.&#xD;
&#xD;
           Measure of treatment quality and adherence All sessions will be videotaped throughout&#xD;
           the study. At least 20% of the tapes will be viewed by the supervisors to ensure&#xD;
           continued treatment quality and adherence to manuals.&#xD;
&#xD;
           Measures&#xD;
&#xD;
           Demographics data:&#xD;
&#xD;
           The following demographics will be registered: Sex, age, Norwegian skills, civil status,&#xD;
           children, education, work status, self-assessment of health, self-assessment of oral&#xD;
           health and substance abuse. The patients register time since last regular appointment&#xD;
           with a dentist.&#xD;
&#xD;
           Level of dental anxiety: Modified Dental Anxiety Scale (MDAS) and Index of dental&#xD;
           anxiety and fear (IDAF-4C+). .&#xD;
&#xD;
           Measures to identify factors that may influence treatment outcome:&#xD;
&#xD;
           Post-traumatic stress disorder: Post-traumatic stress disorder-checklist (PCL).&#xD;
&#xD;
           Depression and anxiety: The hospital anxiety and depression scale (HADS)&#xD;
&#xD;
           Satisfaction with life:&#xD;
&#xD;
           The Satisfaction With Life Scale (SWLS) Oral quality of life: Oral impact on daily&#xD;
           performance (OIDP). Patient-dentist relation: Working Alliance Inventory -12 (WAI-12).&#xD;
&#xD;
           Coping strategies: The dental coping strategy questionnaire (DCSQ). Patient assessment&#xD;
           of the treatment: An questionnaire containing a likert scale assessing how the patients&#xD;
           evaluate different elements of the treatment they have received has been developed based&#xD;
           on similar scales in comparable studies Personality traits: The Big Five Inventory&#xD;
&#xD;
           Dental reports:&#xD;
&#xD;
           Oral examination and assessment of x-rays. Three. dentists separately record oral health&#xD;
           and treatment needs based on the radiographs (BWs and OPG). With access to the initial&#xD;
           clinical recordings, the diagnostic registrations will then be discussed among the three&#xD;
           dentists until a consensus is achieved.&#xD;
&#xD;
           Oral Health: Decayed, missed or filled teeth (DMFT).Root-filled teeth. Remnants of roots&#xD;
           Periradicular bone lesions. Number of third molars.&#xD;
&#xD;
           Oral treatment needs: Number of teeth with need for restorations, periodontal&#xD;
           treatment,root fillings, bridges , dentures and extractions.&#xD;
&#xD;
           Ethics: The study is approved by the Regional Ethics. To make sure the quality of the&#xD;
           intervention meets adequate standards, the dentist will go through training by qualified&#xD;
           personnel before the study is initiated and there will be a continuous surveillance by&#xD;
           watching videotapes of the treatment to ensure that the quality will be upheld&#xD;
           throughout the study.&#xD;
&#xD;
           The associate supervisor of the project, psychologist Bent Storå, will be available for&#xD;
           guidance and help when needed.&#xD;
&#xD;
           Researchers:&#xD;
&#xD;
           Dentist, PhD candidate Mariann Saanum Hauge (MSH), Main supervisor professor dr. odont,&#xD;
           Tiril Willumsen (TW), Associated supervisor clinical psychologist PhD, Bent Storå(BS),&#xD;
           Research assistant, dental secretary Kari Laudal (KL) Financial matters The study&#xD;
           receives financial support from the Norwegian Directorate of Health through the&#xD;
           Specialist Center of Public Dental Health in South Norway.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Each patient receives a project number. A codebook between project number and journal number is stored at Tannhelsetjenestens kompetansesenter sør in Arendal. All data will be registered online using Nettskjema to collect data directly into Services for sensitive data (TSD). The research data from each patient will only be identified by the project number.&#xD;
All data will be stored and analysed using the TSD platform. TSD complies with the directive of privacy and electronic communication in Norway. TSD is developed and operated by USIT, the UiO centre for IT.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Dental anxiety, Dental Anxiety Scale ( MDAS)</measure>
    <time_frame>At baseline, after 3-5 weeks of treatment, after 1 year and after 5 years</time_frame>
    <description>MDAS is a 5 item scale measuring dental anxiety in a range from 5-25. Outcome measure: change in MDAS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Dental Fear</condition>
  <arm_group>
    <arm_group_label>D CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dentist administered cognitive behaviioral treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>D CBT</intervention_name>
    <description>Intervention:&#xD;
a 3-5 session treatment of dental fear.&#xD;
Psychoeducation about anxiety&#xD;
Exploration of the individual anxiety&#xD;
Exposure to the frightening stimuli (no hiding, but actively showing in detail all components of dental treatment, preferably utilizing a mirror while doing treatment).</description>
    <arm_group_label>D CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Intervention:&#xD;
Traditional treatment of dental fear common sense/ benzodiazepine</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Strong dental anxiety that affects the patients self-perceived ability to go through&#xD;
             dental treatment&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Agreement to all the practical arrangements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Not being able to communicate fluently in Norwegian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Willumsen, PdD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <zip>0317</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Hagglin C, Hakeberg M, Ahlqwist M, Sullivan M, Berggren U. Factors associated with dental anxiety and attendance in middle-aged and elderly women. Community Dent Oral Epidemiol. 2000 Dec;28(6):451-60. doi: 10.1034/j.1600-0528.2000.028006451.x.</citation>
    <PMID>11106018</PMID>
  </reference>
  <reference>
    <citation>Hakeberg M, Berggren U, Carlsson SG, Grondahl HG. Long-term effects on dental care behavior and dental health after treatments for dental fear. Anesth Prog. 1993;40(3):72-7.</citation>
    <PMID>7645792</PMID>
  </reference>
  <reference>
    <citation>Hakeberg M, Berggren U. Changes in sick leave among Swedish dental patients after treatment for dental fear. Community Dent Health. 1993 Mar;10(1):23-9.</citation>
    <PMID>8495390</PMID>
  </reference>
  <reference>
    <citation>Schuller AA, Willumsen T, Holst D. Are there differences in oral health and oral health behavior between individuals with high and low dental fear? Community Dent Oral Epidemiol. 2003 Apr;31(2):116-21. doi: 10.1034/j.1600-0528.2003.00026.x.</citation>
    <PMID>12641592</PMID>
  </reference>
  <reference>
    <citation>Armfield JM, Heaton LJ. Management of fear and anxiety in the dental clinic: a review. Aust Dent J. 2013 Dec;58(4):390-407; quiz 531. doi: 10.1111/adj.12118.</citation>
    <PMID>24320894</PMID>
  </reference>
  <reference>
    <citation>Davies JG, Wilson KI, Clements AL. A joint approach to treating dental phobia: a re-evaluation of a collaboration between community dental services and specialist psychotherapy services ten years on. Br Dent J. 2011 Aug 26;211(4):159-62. doi: 10.1038/sj.bdj.2011.674. Erratum In: Br Dent J. 2011;211(6):262.</citation>
    <PMID>21869789</PMID>
  </reference>
  <reference>
    <citation>Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.</citation>
    <PMID>23746494</PMID>
  </reference>
  <reference>
    <citation>Vika M, Skaret E, Raadal M, Ost LG, Kvale G. One- vs. five-session treatment of intra-oral injection phobia: a randomized clinical study. Eur J Oral Sci. 2009 Jun;117(3):279-85. doi: 10.1111/j.1600-0722.2009.00628.x.</citation>
    <PMID>19583756</PMID>
  </reference>
  <reference>
    <citation>Willumsen T, Vassend O. Effects of cognitive therapy, applied relaxation and nitrous oxide sedation. A five-year follow-up study of patients treated for dental fear. Acta Odontol Scand. 2003 Apr;61(2):93-9. doi: 10.1080/00016350310001442.</citation>
    <PMID>12790506</PMID>
  </reference>
  <reference>
    <citation>Brahm CO, Lundgren J, Carlsson SG, Nilsson P, Hultqvist J, Hagglin C. Dentists' skills with fearful patients: education and treatment. Eur J Oral Sci. 2013 Jun;121(3 Pt 2):283-91. doi: 10.1111/eos.12017. Epub 2013 Jan 19.</citation>
    <PMID>23659263</PMID>
  </reference>
  <reference>
    <citation>Strom K, Ronneberg A, Skaare AB, Espelid I, Willumsen T. Dentists' use of behavioural management techniques and their attitudes towards treating paediatric patients with dental anxiety. Eur Arch Paediatr Dent. 2015 Aug;16(4):349-55. doi: 10.1007/s40368-014-0169-1. Epub 2015 Mar 10.</citation>
    <PMID>25753025</PMID>
  </reference>
  <reference>
    <citation>Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.</citation>
    <PMID>7584581</PMID>
  </reference>
  <reference>
    <citation>Armfield JM. Development and psychometric evaluation of the Index of Dental Anxiety and Fear (IDAF-4C+). Psychol Assess. 2010 Jun;22(2):279-87. doi: 10.1037/a0018678.</citation>
    <PMID>20528055</PMID>
  </reference>
  <reference>
    <citation>Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.</citation>
    <PMID>26606250</PMID>
  </reference>
  <reference>
    <citation>Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.</citation>
    <PMID>6880820</PMID>
  </reference>
  <reference>
    <citation>Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.</citation>
    <PMID>16367493</PMID>
  </reference>
  <reference>
    <citation>Astrom AN, Haugejorden O, Skaret E, Trovik TA, Klock KS. Oral Impacts on Daily Performance in Norwegian adults: validity, reliability and prevalence estimates. Eur J Oral Sci. 2005 Aug;113(4):289-96. doi: 10.1111/j.1600-0722.2005.00225.x.</citation>
    <PMID>16048520</PMID>
  </reference>
  <reference>
    <citation>Haugejorden O, Klock KS, Astrom AN, Skaret E, Trovik TA. Socio-economic inequality in the self-reported number of natural teeth among Norwegian adults--an analytical study. Community Dent Oral Epidemiol. 2008 Jun;36(3):269-78. doi: 10.1111/j.1600-0528.2007.00367.x.</citation>
    <PMID>18474059</PMID>
  </reference>
  <reference>
    <citation>Bernson JM, Elfstrom ML, Hakeberg M. Adaptive coping strategies among adults with dental fear. Further development of a new version of the Dental Coping Strategy Questionnaire. Acta Odontol Scand. 2012 Sep;70(5):414-20. doi: 10.3109/00016357.2011.634830. Epub 2011 Nov 30.</citation>
    <PMID>22126426</PMID>
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    <PMID>8427480</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Tiril Willumsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293342
org study id: REC-2017/97
nct id: NCT03293342
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an RCT study comparing a 3-5 intervention treatment with dentist administered
      Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a
      "treatment as usual" concept using premedication with benzodiazepines and a common sense
      approach.

      The treatment will be performed in a regular dental office. The dentist is working as a
      regular dentist and is trained in the CBT Method.
Brief Summary:

      The study is an randomized clinical trial (RCT) comparing a 3-5 intervention treatment with
      dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The
      control treatment is a "treatment as usual" concept using premedication with benzodiazepines
      and a common sense approach.

      The treatment will be performed in a regular dental office. The dentist is working as a
      regular dentist and is trained in the CBT Method.

      Detailed Description:

      Background Dental fear is common in adults and has a prevalence of about 10-25%.
      Approximately 2/3 of fearful patients manage to get through treatment, but with great
      discomfort. The remaining 1/3 avoid dental visits and some of them qualify for the diagnosis
      odontophobia (prevalence 1,4-7,1%).

      Several studies demonstrate reduced oral health in people with dental fear and odontophobia
      compared to the general population.

      Dental phobia often develops gradually and patients' dental health would often benefit from
      treatment of dental anxiety before the manifestations of phobia; before dental health
      deteriorate and avoidance of dental treatment has lasted too long.

      Consequently, it would be beneficial if dental anxiety were effectively treated in a dentist
      general practice and thereby easily accessible. Thus there is a need for evidence based
      treatment methods for this context.

      Psychological treatment of dental phobia is well documented in multidisciplinary treatment
      programmes were psychologists and dentists work together. However, there is a lack of
      psychologist resources and high cost of a treatment approach that requires 2 specialists.
      This emphasises the need for treatment programs of dental anxiety within dentist's
      competence. Dentists can, provided the right training, be successful in the utilisation of
      psychological techniques for the treatment of anxiety. Willumsen et al developed and tested
      dental anxiety treatment methods including the use of CBT interventions for use by dentists.
      This RCT study showed good results at post treatment, also in a 5 year follow up. Two CBT
      methods (applied relaxation and cognitive therapy) with contrasting principles (relaxation vs
      activation) were tested against nitrous oxide sedation. All three treatment approaches showed
      adequate effect but CBT interventions were superior in a longer time perspective. However,
      the treatment methods were resource demanding; requiring 10 sessions of treatment. It would
      therefore be beneficial to develop a shorter method of treatment that could be used by a
      dentist in a general practice and also to test its use within the context of a regular dental
      practice.

      Premedication with benzodiazepines and a common sense approach including tell-show-do is the
      recommended and most frequent used alternative in Norway when treating this group of patients
      in general dental practice; Therefore the study is designed to compare the psychological
      intervention with these treatment modalities to explore differences in effect.

      The hypothesis is that a treatment programme with D-CBT have more reduction of dental fear
      than traditional treatment with common sense/ premedication

      The aims:

        1. Test D-CBT against a combined pharmacological common sense approach in a RCT study
           performed in a general dental practice.

        2. To explore whether demographical data, levels of dental fear, comorbidity, coping
           strategies or dentist-patient relation can predict treatment outcome of D-CBT.

        3. To do a 1-year- and 3 year follow-up on the RCT-patients with assessment of levels of
           dental fear in the patient, quality of life, oral quality of life and ability to receive
           dental treatment.

           Methods Design The study is a randomized controlled trial. Population Patients will be
           recruited through written and oral information to local dentists and physicians,
           advertising in local newspapers or referred from a waiting list at a local dental fear
           clinic .

           Criteria for inclusion

             -  Strong dental anxiety that affects the patients self-perceived ability to go
                through dental treatment

             -  Age over 18

             -  Agreement to all the practical arrangements of the study Criteria for exclusion

             -  Substance abuse

             -  Not being able to communicate fluently in Norwegian Sample size Sample size was
                estimated with power (1-Betta) 0,8 og type error (alfa) 5%. From these criteria
                sample size was calculated to 30 in each group. Drop out is expected to be about
                15% giving 35 participants in each group and a total of 70 participants in the
                RCT-study.

           Location and operator The study will be performed in a general dental practice in
           Mandal, a small town in the south of Norway. All patients will be treated by the same
           dentist, an experienced private practitioner with an interest in treating dentally
           anxious patients; MSH.

           Research psychologists and dentists experienced in treating patients with dental fear
           have developed the dentist-based cognitive behaviour treatment method (D-CBT). D-CBT is
           based on existing literature.

           In addition an expert group consisting of clinical psychologists and dentists, all of
           which are experienced in treating dental anxiety, have assessed the practical aspects of
           implementing the method and manual.

           A manual describes the intervention in detail. The method will be tested in 5 patients
           in a pilot study.

           Randomisation procedure Patients are randomized in two groups by simple randomisation.
           Lists will be constructed by statistical software and treatments will then be allocated
           to patients in sequence using numbered opaque envelopes containing treatment
           allocations.

           The intervention group All patients in the D-CBT group will go through 3- 5
           consultations with a duration of 60 minutes or 3 sessions of 90 minutes aimed at
           treating their dental anxiety. The appointments will be spaced with a maximum of 2 weeks
           to minimize the setback that will often occur between appointments (detailed description
           in appendix).

           All sessions will be videotaped throughout the study. The control group The
           non-intervention group will be offered premedication with midazolam during dental
           treatment per standard procedures. Common sense principles as communication skills,
           control and tell-show-do will be implemented.

           Similarities between the control and the intervention groups:

             -  Building a good relation with the patient

             -  Stop signal will be utilized

             -  Explain and show what the dentist wants to do before doing treatment (tell-show-do)

             -  The treatment should be as painless as possible

           Differences between the control and the intervention groups:

           Midazolam/tell-show-do

             -  Sedation is an alternative

             -  Minimalizing exposure to the patient (for example hiding instead of showing the
                syringe while putting the anaesthetics).

           Psycological intervention -characteristics

             -  Psychoeducation about anxiety

             -  Exploration of the individual anxiety

             -  Exposure to the frightening stimuli (no hiding, but actively showing in detail all
                components of dental treatment, preferably utilizing a mirror while doing
                treatment).

           Data Each patient receives a project number. A codebook between project number and
           journal number is stored at the Specialist Center of Public Dental Health in South
           Norway All data will be registered online using Nettskjema to collect data directly into
           Services for sensitive data (TSD). The research data from each patient will only be
           identified by the project number.

           All data will be stored and analysed using the TSD platform. TSD complies with the
           directive of privacy and electronic communication in Norway. TSD is developed and
           operated by the University of Oslos' centre for IT (USIT).

           Only MSH and the supervisors will be given access to the data in TSD. All video
           recordings will be stored on encrypted memory sticks locked in a filing cabinet. The key
           to the filing cabinet is kept in a key cabinet locked by a code. The code is known only
           by the dentist (MSH) and the dental secretary (KL). The recordings will be stored up
           until publication of articles and TW is responsible for deleting them.

           Statistics The current project uses a traditional experimental research design to assess
           the research hypothesis. In order to compare differences between the 35 participants in
           the two research conditions the data will be analysed with regression analysis. A 2x2
           repeated measures ANOVA will be used to test if the experimental condition of five
           sessions of D-CBT treatment is superior to the control condition of premedication and
           gradual habituation. A factor analytic approach will be used to assess the level of
           influence on the results by factors like: age; gender; social economic status and
           substance abuse. The statistical analysis will be completed using the IBM SPSS
           statistical software version 16.0.

           Measure of treatment quality and adherence All sessions will be videotaped throughout
           the study. At least 20% of the tapes will be viewed by the supervisors to ensure
           continued treatment quality and adherence to manuals.

           Measures

           Demographics data:

           The following demographics will be registered: Sex, age, Norwegian skills, civil status,
           children, education, work status, self-assessment of health, self-assessment of oral
           health and substance abuse. The patients register time since last regular appointment
           with a dentist.

           Level of dental anxiety: Modified Dental Anxiety Scale (MDAS) and Index of dental
           anxiety and fear (IDAF-4C+). .

           Measures to identify factors that may influence treatment outcome:

           Post-traumatic stress disorder: Post-traumatic stress disorder-checklist (PCL).

           Depression and anxiety: The hospital anxiety and depression scale (HADS)

           Satisfaction with life:

           The Satisfaction With Life Scale (SWLS) Oral quality of life: Oral impact on daily
           performance (OIDP). Patient-dentist relation: Working Alliance Inventory -12 (WAI-12).

           Coping strategies: The dental coping strategy questionnaire (DCSQ). Patient assessment
           of the treatment: An questionnaire containing a likert scale assessing how the patients
           evaluate different elements of the treatment they have received has been developed based
           on similar scales in comparable studies Personality traits: The Big Five Inventory

           Dental reports:

           Oral examination and assessment of x-rays. Three. dentists separately record oral health
           and treatment needs based on the radiographs (BWs and OPG). With access to the initial
           clinical recordings, the diagnostic registrations will then be discussed among the three
           dentists until a consensus is achieved.

           Oral Health: Decayed, missed or filled teeth (DMFT).Root-filled teeth. Remnants of roots
           Periradicular bone lesions. Number of third molars.

           Oral treatment needs: Number of teeth with need for restorations, periodontal
           treatment,root fillings, bridges , dentures and extractions.

           Ethics: The study is approved by the Regional Ethics. To make sure the quality of the
           intervention meets adequate standards, the dentist will go through training by qualified
           personnel before the study is initiated and there will be a continuous surveillance by
           watching videotapes of the treatment to ensure that the quality will be upheld
           throughout the study.

           The associate supervisor of the project, psychologist Bent Storå, will be available for
           guidance and help when needed.

           Researchers:

           Dentist, PhD candidate Mariann Saanum Hauge (MSH), Main supervisor professor dr. odont,
           Tiril Willumsen (TW), Associated supervisor clinical psychologist PhD, Bent Storå(BS),
           Research assistant, dental secretary Kari Laudal (KL) Financial matters The study
           receives financial support from the Norwegian Directorate of Health through the
           Specialist Center of Public Dental Health in South Norway.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Clinical Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Each patient receives a project number. A codebook between project number and journal number is stored at Tannhelsetjenestens kompetansesenter sør in Arendal. All data will be registered online using Nettskjema to collect data directly into Services for sensitive data (TSD). The research data from each patient will only be identified by the project number.
All data will be stored and analysed using the TSD platform. TSD complies with the directive of privacy and electronic communication in Norway. TSD is developed and operated by USIT, the UiO centre for IT.
measure: Level of Dental anxiety, Dental Anxiety Scale ( MDAS)
time frame: At baseline, after 3-5 weeks of treatment, after 1 year and after 5 years
description: MDAS is a 5 item scale measuring dental anxiety in a range from 5-25. Outcome measure: change in MDAS
arm group label: D CBT
arm group type: Experimental
description: Dentist administered cognitive behaviioral treatment
arm group label: Control
arm group type: Active Comparator
description: Treatment as usual
intervention type: Behavioral
intervention name: D CBT
description: Intervention:
a 3-5 session treatment of dental fear.
Psychoeducation about anxiety
Exploration of the individual anxiety
Exposure to the frightening stimuli (no hiding, but actively showing in detail all components of dental treatment, preferably utilizing a mirror while doing treatment).
arm group label: D CBT
intervention type: Combination Product
intervention name: Control
description: Intervention:
Traditional treatment of dental fear common sense/ benzodiazepine
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Professor Willumsen, PdD
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Norway
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responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Tiril Willumsen
investigator title: Professor
sharing ipd: No