<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/NCT04477551</url>
  </required_header>
  <id_info>
    <org_study_id>MBRU/IRB/2020/006</org_study_id>
    <nct_id>NCT04477551</nct_id>
  </id_info>
  <brief_title>The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis</brief_title>
  <official_title>The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammed Bin Rashid University of Medicine and Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mohammed Bin Rashid University of Medicine and Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Periodontal disease is serious and global chronic disease. The prevalence of periodontal&#xD;
      diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed&#xD;
      that one in five patients has received periodontal treatment in recent years.&#xD;
&#xD;
      Several studies reported the additional benefits provided by the use of diode laser in&#xD;
      combination with ultrasonic debridement in the treatment of gum disease. The use of diode&#xD;
      laser may debridement of deep pocketing areas while improving healing of gum tissues.&#xD;
&#xD;
      The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from&#xD;
      deep tooth pocket using combined diode laser and conventional pocket debridement versus&#xD;
      conventional pocket debridement alone on tooth supporting tissue parameters in patients with&#xD;
      advanced gum disease (periodontitis).&#xD;
&#xD;
      Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to&#xD;
      two groups: a control group, which will receive conventional pocket debridement and a test&#xD;
      group which will receive ultrasonic debridement with diode laser. Gum measurements will be&#xD;
      recorded by a masked calibrated examiner at six points for each tooth and patients'&#xD;
      postoperative experience and satisfaction will be assessed using special forms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">October 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 28, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Full mouth plaque score (FMPS).</measure>
    <time_frame>Change from baseline FMPS at six months</time_frame>
    <description>The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Full mouth bleeding score (FMBS).</measure>
    <time_frame>Change from baseline FMBS at six months</time_frame>
    <description>The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probing pocket depth (PPD).</measure>
    <time_frame>Change from baseline PPDs at six months</time_frame>
    <description>PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical attachment level (CAL).</measure>
    <time_frame>Change from baseline CALs at six months</time_frame>
    <description>CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of sites PPDs ≥ 6 mm.</measure>
    <time_frame>Change from baseline number of sites with PPDs ≥ 6 mm at six months</time_frame>
    <description>Number of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of sites PPDs ≥ 6 mm.</measure>
    <time_frame>Change from baseline percentages of sites with PPDs ≥ 6 mm at six months</time_frame>
    <description>Percentages of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operating time</measure>
    <time_frame>Outcome measures will be recorded at baseline</time_frame>
    <description>Time required to complete the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Change from baseline pain at seven days</time_frame>
    <description>Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative swelling</measure>
    <time_frame>Change from baseline swelling at seven days</time_frame>
    <description>Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bleeding</measure>
    <time_frame>Change from baseline bleeding at seven days</time_frame>
    <description>Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bruising</measure>
    <time_frame>Change from baseline bruising at seven days</time_frame>
    <description>Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative root sensitivity</measure>
    <time_frame>Change from baseline root sensitivity at seven days</time_frame>
    <description>Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measures</measure>
    <time_frame>Change from baseline GOHAI score at six months days</time_frame>
    <description>Patient's quality of life will be evaluated using general oral health assessment index (GOHAI). The GOHAI has 12 negatively and positively worded items evaluating three dimensions of oral health related quality of life (physical function, pain or discomfort and psychosocial function).&#xD;
The score ranged from 0 to 60. The scores are maintained for the three items &quot;able to swallow comfortably&quot;, able to eat without discomfort&quot;, &quot;pleased with look of teeth&quot;, and reversed for the remaining nine items, so that a higher score was associated with a more positive oral health.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Diode laser (device) with scaling and root planing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diode laser (device) with conventional scaling and root planing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional scaling and root planing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional scaling and root planing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diode laser (device) with scaling and root planing</intervention_name>
    <description>Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.</description>
    <arm_group_label>Diode laser (device) with scaling and root planing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional scaling and root planing</intervention_name>
    <description>Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.</description>
    <arm_group_label>Conventional scaling and root planing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or over.&#xD;
&#xD;
          -  Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.&#xD;
&#xD;
          -  Good compliance and commitment to attend follow-up review appointments.&#xD;
&#xD;
          -  Willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received periodontal treatment in the last 12 months.&#xD;
&#xD;
          -  Received systemic antibiotic in the last 6 months.&#xD;
&#xD;
          -  Pregnancy or lactating participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Momen A Atieh, BDS, MSc, DClinDent, PhD</last_name>
    <phone>+97143838905</phone>
    <email>momen.atieh@mbru.ac.ae</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dubai Dental Hospital</name>
      <address>
        <city>Dubai</city>
        <zip>505097</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Momen A Atieh, BDS, MSc, DClinDent, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 11, 2021</last_update_submitted>
  <last_update_submitted_qc>September 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mohammed Bin Rashid University of Medicine and Health Sciences</investigator_affiliation>
    <investigator_full_name>Associate Professor Momen Atieh</investigator_full_name>
    <investigator_title>Chair and Associate Professor (Periodontology)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04477551
org study id: MBRU/IRB/2020/006
nct id: NCT04477551
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Periodontal disease is serious and global chronic disease. The prevalence of periodontal
      diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed
      that one in five patients has received periodontal treatment in recent years.

      Several studies reported the additional benefits provided by the use of diode laser in
      combination with ultrasonic debridement in the treatment of gum disease. The use of diode
      laser may debridement of deep pocketing areas while improving healing of gum tissues.

      The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from
      deep tooth pocket using combined diode laser and conventional pocket debridement versus
      conventional pocket debridement alone on tooth supporting tissue parameters in patients with
      advanced gum disease (periodontitis).

      Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to
      two groups: a control group, which will receive conventional pocket debridement and a test
      group which will receive ultrasonic debridement with diode laser. Gum measurements will be
      recorded by a masked calibrated examiner at six points for each tooth and patients'
      postoperative experience and satisfaction will be assessed using special forms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Full mouth plaque score (FMPS).
time frame: Change from baseline FMPS at six months
description: The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.
measure: Full mouth bleeding score (FMBS).
time frame: Change from baseline FMBS at six months
description: The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.
measure: Probing pocket depth (PPD).
time frame: Change from baseline PPDs at six months
description: PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
measure: Clinical attachment level (CAL).
time frame: Change from baseline CALs at six months
description: CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.
measure: Number of sites PPDs ≥ 6 mm.
time frame: Change from baseline number of sites with PPDs ≥ 6 mm at six months
description: Number of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
measure: Percentages of sites PPDs ≥ 6 mm.
time frame: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
description: Percentages of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
measure: Operating time
time frame: Outcome measures will be recorded at baseline
description: Time required to complete the procedure
measure: Postoperative pain
time frame: Change from baseline pain at seven days
description: Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
measure: Postoperative swelling
time frame: Change from baseline swelling at seven days
description: Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
measure: Postoperative bleeding
time frame: Change from baseline bleeding at seven days
description: Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
measure: Postoperative bruising
time frame: Change from baseline bruising at seven days
description: Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
measure: Postoperative root sensitivity
time frame: Change from baseline root sensitivity at seven days
description: Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
measure: Quality of life measures
time frame: Change from baseline GOHAI score at six months days
description: Patient's quality of life will be evaluated using general oral health assessment index (GOHAI). The GOHAI has 12 negatively and positively worded items evaluating three dimensions of oral health related quality of life (physical function, pain or discomfort and psychosocial function).
The score ranged from 0 to 60. The scores are maintained for the three items "able to swallow comfortably", able to eat without discomfort", "pleased with look of teeth", and reversed for the remaining nine items, so that a higher score was associated with a more positive oral health.
arm group label: Diode laser (device) with scaling and root planing
arm group type: Experimental
description: Diode laser (device) with conventional scaling and root planing
arm group label: Conventional scaling and root planing
arm group type: Active Comparator
description: Conventional scaling and root planing
intervention type: Procedure
intervention name: Diode laser (device) with scaling and root planing
description: Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
arm group label: Diode laser (device) with scaling and root planing
intervention type: Procedure
intervention name: Conventional scaling and root planing
description: Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
arm group label: Conventional scaling and root planing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Momen A Atieh, BDS, MSc, DClinDent, PhD
phone: +97143838905
email: momen.atieh@mbru.ac.ae
facility: 
status: Recruiting
contact: 
country: United Arab Emirates
responsible party type: Principal Investigator
investigator affiliation: Mohammed Bin Rashid University of Medicine and Health Sciences
investigator full name: Associate Professor Momen Atieh
investigator title: Chair and Associate Professor (Periodontology)
mesh term: Periodontitis
mesh term: Periodontal Diseases
sharing ipd: Undecided