<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/NCT03761264</url>
  </required_header>
  <id_info>
    <org_study_id>RP053A-17HTM</org_study_id>
    <nct_id>NCT03761264</nct_id>
  </id_info>
  <brief_title>Systemic and Local Antimicrobials in the Management of Dental Abscess in Children</brief_title>
  <official_title>Clinical, Microbiological and Quality of Life Outcomes Following Use of Systemic and Local Antimicrobials in the Management of Odontogenic Infections in Paediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dental infections originating in the teeth are routinely managed systemically with a course&#xD;
      of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental&#xD;
      infections can also be managed by removing the offending cause of the infection followed by&#xD;
      placement of an intra-canal medication which acts as a local antimicrobial. Intra-canal&#xD;
      medicaments are being used in clinical practice following root canal treatment. The&#xD;
      investigators hypothesize that the effect of intra-canal antimicrobials in the management of&#xD;
      dental infections will be the better than oral antibiotics in terms of clinical , microbial&#xD;
      and oral- health quality of life parameters. This will be a three-arm, parallel, comparative,&#xD;
      randomized study with the aim of assessing the efficacy of intra-canal medication and oral&#xD;
      antibiotics in reducing the infection and treatment of odontogenic infections, based on signs&#xD;
      and symptoms and microbial count. The study will be performed in child participants between&#xD;
      the age group of 3 to 11 years presenting with acute odontogenic infections. Participants&#xD;
      will be randomized by block randomization. The treatment duration of the study will be at&#xD;
      least 5 days or maximum 7 days depending upon the response. Participants will be assessed on&#xD;
      Day 3 and Day 5/7. Concurrently, the oral health-related quality of life (OHRQoL) following&#xD;
      these clinical interventions in children will be recorded and again on Day 14. Quantitative&#xD;
      assessment of microorganisms seen in the root canals and the changes seen in the microbial&#xD;
      flora through the treatment will help us to determine the best antimicrobial agent to be used&#xD;
      in the management of odontogenic infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will comprise of a three-arm, parallel, comparative, randomized treatment of&#xD;
      children aged 3 to 11 years presenting with acute odontogenic infection. The three arms of&#xD;
      the study includes 1) Odontopaste® as a one time intra-canal placement, 2) Calcium hydroxide&#xD;
      (gold standard) as a one time intra-canal placement and 3) a course of amoxicillin three&#xD;
      times daily for 5 days administered orally with meal. Patients will not receive additional&#xD;
      medical therapy such as analgesics or anti-inflammatory drugs. The participants will be&#xD;
      selected for the treatment based on a block randomization in groups of three. On Day 1 after&#xD;
      confirming the eligibility based on clinical examination and radiographic finding, informed&#xD;
      consent will be obtained. At baseline (Day 1), clinical parameters including pain,swelling,&#xD;
      regional lymphadenitis, percussion of the tooth, trismus, fistula and pus discharge will be&#xD;
      recorded. Participant will undergo an intervention whereby the tooth will be opened from the&#xD;
      clinical crown followed by microbiological sampling, drainage and irrigation of the tooth,&#xD;
      intra-canal medicament placed in the canals according to randomization and the cavity sealed&#xD;
      with a Glass ionomer cement. Participants in the oral antibiotic group will have no&#xD;
      intra-canal medicament placed and instead a sterile cotton pellet placed. Simultaneously, the&#xD;
      Malay-ECOHIS will be given to the parent/guardian of the participant. The microbiological&#xD;
      sampling will be stored in an appropriate transport medium and sent to the central laboratory&#xD;
      for quantitative assessment via quantitative polymerase chain reaction (qPCR) using SYBR®&#xD;
      Green. Participants will be assessed on Day 3 for clinical parameters and the integrity of&#xD;
      restoration. The next and final assessment will be done at Day 5/7, where clinical parameters&#xD;
      will be recorded along with microbiological sampling as in Day 1. The Malay-ECOHIS survey&#xD;
      will be repeated. The primary objective of the study is to assess the resolution of the&#xD;
      infection based on 1) clinical parameters, 2) microbiological sampling and 3) oral health&#xD;
      quality of life. The treatment will be carried out by five operators who are calibrated and&#xD;
      the individual sub components such as recording clinical parameters, microbiological sampling&#xD;
      and assessing the OHRQoL questionnaire will be carried out by the same operator respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2018</start_date>
  <completion_date type="Actual">February 13, 2020</completion_date>
  <primary_completion_date type="Actual">February 13, 2020</primary_completion_date>
  <phase>Phase 2</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Temperature Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Trismus Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Percussion Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Fistula Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7</measure>
    <time_frame>Baseline, Days 3, 5 or 7</time_frame>
    <description>Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7</measure>
    <time_frame>Baseline, Day 5 or Day 7</time_frame>
    <description>Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change of ECOHIS scores from baseline and at Day 5 or Day 7</measure>
    <time_frame>Baseline, Day 5 or Day 7</time_frame>
    <description>Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = &quot;I don't know&quot;. The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of Individual Target Species</measure>
    <time_frame>First 2 Months of Study</time_frame>
    <description>A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Dentoalveolar Abscess</condition>
  <arm_group>
    <arm_group_label>Intra-canal Odontopaste®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single visit placement of Odontopaste®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intra-canal Pulpdent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single visit placement of Pulpdent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Amoxicillin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amoxicillin 15mg/kg tds for 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Odontopaste®</intervention_name>
    <description>Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste® will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.</description>
    <arm_group_label>Intra-canal Odontopaste®</arm_group_label>
    <other_name>Zinc Oxide based endodontic dressing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pulpdent</intervention_name>
    <description>Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.</description>
    <arm_group_label>Intra-canal Pulpdent</arm_group_label>
    <other_name>Calcium hydroxide endodontic paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days</description>
    <arm_group_label>Oral Amoxicillin</arm_group_label>
    <other_name>Amoxycillin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with acute odontogenic infections on primary teeth with evidence&#xD;
             of intra-oral / extra- oral swelling and pus discharge&#xD;
&#xD;
          -  Absence of any systemic disease&#xD;
&#xD;
          -  Age group between 3-11 years&#xD;
&#xD;
          -  Malaysian citizen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients taking antibiotics 30 days prior to their attendance to the department&#xD;
&#xD;
          -  Presence of any systemic disease&#xD;
&#xD;
          -  Patients with cellulitis&#xD;
&#xD;
          -  Patients suffering from spreading odontogenic infections which require hospitalization&#xD;
             or immediate IV antibiotic treatment&#xD;
&#xD;
          -  Tooth with poor prognosis for extraction&#xD;
&#xD;
          -  Extensively resorbed roots (&gt; 2/3rd)&#xD;
&#xD;
          -  Patients allergic or resistance to amoxicillin&#xD;
&#xD;
          -  Non-Malaysian citizen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shani Ann Mani Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Syarida Hasnur Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lily Azura Shoaib Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Malaya</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <link>
    <url>http://pdfs.semanticscholar.org/2e49/67ff2f0a06e4b4707d3f0b1436d7b437d91f.pdf</url>
    <description>Intra Canal Treatments for Clinical Success and Patient Comfort</description>
  </link>
  <link>
    <url>http://www.aae.org/specialty/wp-content/uploads/sites/2/2017/06/aae_systemic-antibiotics.pdf</url>
    <description>American Association of Endodontics (AAE) Guidance on the Use of Systemic Antibiotics in Endodontics</description>
  </link>
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    <citation>Robertson D, Smith AJ. The microbiology of the acute dental abscess. J Med Microbiol. 2009 Feb;58(Pt 2):155-162. doi: 10.1099/jmm.0.003517-0.</citation>
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    <citation>Walsh LJ. Serious complications of endodontic infections: some cautionary tales. Aust Dent J. 1997 Jun;42(3):156-9. doi: 10.1111/j.1834-7819.1997.tb00113.x.</citation>
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    <citation>Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.</citation>
    <PMID>8734709</PMID>
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    <citation>Lewis MA. Why we must reduce dental prescription of antibiotics: European Union Antibiotic Awareness Day. Br Dent J. 2008 Nov 22;205(10):537-8. doi: 10.1038/sj.bdj.2008.984.</citation>
    <PMID>19023306</PMID>
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    <citation>Dar-Odeh N, Ryalat S, Shayyab M, Abu-Hammad O. Analysis of clinical records of dental patients attending Jordan University Hospital: Documentation of drug prescriptions and local anesthetic injections. Ther Clin Risk Manag. 2008 Oct;4(5):1111-7. doi: 10.2147/tcrm.s3727.</citation>
    <PMID>19209291</PMID>
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    <citation>Dar-Odeh NS, Abu-Hammad OA, Al-Omiri MK, Khraisat AS, Shehabi AA. Antibiotic prescribing practices by dentists: a review. Ther Clin Risk Manag. 2010 Jul 21;6:301-6. doi: 10.2147/tcrm.s9736.</citation>
    <PMID>20668712</PMID>
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    <citation>Hills-Smith H, Schuman NJ. Antibiotic therapy in pediatric dentistry. II. Treatment of oral infection and management of systemic disease. Pediatr Dent. 1983 Mar;5(1):45-50. No abstract available.</citation>
    <PMID>6344030</PMID>
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    <citation>Bansal R, Jain A. Overview on the current antibiotic containing agents used in endodontics. N Am J Med Sci. 2014 Aug;6(8):351-8. doi: 10.4103/1947-2714.139277.</citation>
    <PMID>25210667</PMID>
  </reference>
  <reference>
    <citation>Farhad A, Mohammadi Z. Calcium hydroxide: a review. Int Dent J. 2005 Oct;55(5):293-301. doi: 10.1111/j.1875-595x.2005.tb00326.x.</citation>
    <PMID>16245464</PMID>
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  <reference>
    <citation>Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.</citation>
    <PMID>16939452</PMID>
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    <citation>Matijevic S, Lazic Z, Kuljic-Kapulica N, Nonkovic Z. Empirical antimicrobial therapy of acute dentoalveolar abscess. Vojnosanit Pregl. 2009 Jul;66(7):544-50. doi: 10.2298/vsp0907544m.</citation>
    <PMID>19678579</PMID>
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    <citation>Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.</citation>
    <PMID>28931398</PMID>
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    <citation>Siqueira JF Jr, Rocas IN, Lopes HP. Patterns of microbial colonization in primary root canal infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Feb;93(2):174-8. doi: 10.1067/moe.2002.119910.</citation>
    <PMID>11862207</PMID>
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    <citation>Frisch MB, Clark MP, Rouse SV, Rudd MD, Paweleck JK, Greenstone A, Kopplin DA. Predictive and treatment validity of life satisfaction and the quality of life inventory. Assessment. 2005 Mar;12(1):66-78. doi: 10.1177/1073191104268006.</citation>
    <PMID>15695744</PMID>
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    <citation>Locker D. Measuring oral health: a conceptual framework. Community Dent Health. 1988 Mar;5(1):3-18. No abstract available.</citation>
    <PMID>3285972</PMID>
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    <citation>Jackson SL, Vann WF Jr, Kotch JB, Pahel BT, Lee JY. Impact of poor oral health on children's school attendance and performance. Am J Public Health. 2011 Oct;101(10):1900-6. doi: 10.2105/AJPH.2010.200915. Epub 2011 Feb 17.</citation>
    <PMID>21330579</PMID>
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    <citation>Al-Malik M, Al-Sarheed M. Pattern of management of oro-facial infection in children: A retrospective. Saudi J Biol Sci. 2017 Sep;24(6):1375-1379. doi: 10.1016/j.sjbs.2016.03.004. Epub 2016 Mar 31.</citation>
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  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>May 10, 2020</last_update_submitted>
  <last_update_submitted_qc>May 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Dr. Shani Ann Mani</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Odontogenic Infections</keyword>
  <keyword>Paediatric Patients</keyword>
  <keyword>Local Antimicrobials</keyword>
  <keyword>Systemic Antimicrobials</keyword>
  <keyword>Dentoalveolar Abscess</keyword>
  <keyword>Apical Dentoalveolar Abscess</keyword>
  <keyword>Periapical Abscess</keyword>
  <keyword>Suppurative Periapical Periodontitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Periapical Abscess</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Zinc Oxide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03761264/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03761264/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03761264
org study id: RP053A-17HTM
nct id: NCT03761264
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Dental infections originating in the teeth are routinely managed systemically with a course
      of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental
      infections can also be managed by removing the offending cause of the infection followed by
      placement of an intra-canal medication which acts as a local antimicrobial. Intra-canal
      medicaments are being used in clinical practice following root canal treatment. The
      investigators hypothesize that the effect of intra-canal antimicrobials in the management of
      dental infections will be the better than oral antibiotics in terms of clinical , microbial
      and oral- health quality of life parameters. This will be a three-arm, parallel, comparative,
      randomized study with the aim of assessing the efficacy of intra-canal medication and oral
      antibiotics in reducing the infection and treatment of odontogenic infections, based on signs
      and symptoms and microbial count. The study will be performed in child participants between
      the age group of 3 to 11 years presenting with acute odontogenic infections. Participants
      will be randomized by block randomization. The treatment duration of the study will be at
      least 5 days or maximum 7 days depending upon the response. Participants will be assessed on
      Day 3 and Day 5/7. Concurrently, the oral health-related quality of life (OHRQoL) following
      these clinical interventions in children will be recorded and again on Day 14. Quantitative
      assessment of microorganisms seen in the root canals and the changes seen in the microbial
      flora through the treatment will help us to determine the best antimicrobial agent to be used
      in the management of odontogenic infections.
This study will comprise of a three-arm, parallel, comparative, randomized treatment of
      children aged 3 to 11 years presenting with acute odontogenic infection. The three arms of
      the study includes 1) Odontopaste® as a one time intra-canal placement, 2) Calcium hydroxide
      (gold standard) as a one time intra-canal placement and 3) a course of amoxicillin three
      times daily for 5 days administered orally with meal. Patients will not receive additional
      medical therapy such as analgesics or anti-inflammatory drugs. The participants will be
      selected for the treatment based on a block randomization in groups of three. On Day 1 after
      confirming the eligibility based on clinical examination and radiographic finding, informed
      consent will be obtained. At baseline (Day 1), clinical parameters including pain,swelling,
      regional lymphadenitis, percussion of the tooth, trismus, fistula and pus discharge will be
      recorded. Participant will undergo an intervention whereby the tooth will be opened from the
      clinical crown followed by microbiological sampling, drainage and irrigation of the tooth,
      intra-canal medicament placed in the canals according to randomization and the cavity sealed
      with a Glass ionomer cement. Participants in the oral antibiotic group will have no
      intra-canal medicament placed and instead a sterile cotton pellet placed. Simultaneously, the
      Malay-ECOHIS will be given to the parent/guardian of the participant. The microbiological
      sampling will be stored in an appropriate transport medium and sent to the central laboratory
      for quantitative assessment via quantitative polymerase chain reaction (qPCR) using SYBR®
      Green. Participants will be assessed on Day 3 for clinical parameters and the integrity of
      restoration. The next and final assessment will be done at Day 5/7, where clinical parameters
      will be recorded along with microbiological sampling as in Day 1. The Malay-ECOHIS survey
      will be repeated. The primary objective of the study is to assess the resolution of the
      infection based on 1) clinical parameters, 2) microbiological sampling and 3) oral health
      quality of life. The treatment will be carried out by five operators who are calibrated and
      the individual sub components such as recording clinical parameters, microbiological sampling
      and assessing the OHRQoL questionnaire will be carried out by the same operator respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews.
measure: Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews.
measure: Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful.
measure: Mean Change From Baseline in Temperature Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)
measure: Mean Change From Baseline in Trismus Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm).
measure: Mean Change From Baseline in Percussion Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness.
measure: Mean Change From Baseline in Fistula Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula
measure: Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7
time frame: Baseline, Days 3, 5 or 7
description: Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge.
measure: Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7
time frame: Baseline, Day 5 or Day 7
description: Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment.
measure: Mean change of ECOHIS scores from baseline and at Day 5 or Day 7
time frame: Baseline, Day 5 or Day 7
description: Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = "I don't know". The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7.
measure: Quantification of Individual Target Species
time frame: First 2 Months of Study
description: A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species.
arm group label: Intra-canal Odontopaste®
arm group type: Experimental
description: Single visit placement of Odontopaste®
arm group label: Intra-canal Pulpdent
arm group type: Active Comparator
description: Single visit placement of Pulpdent
arm group label: Oral Amoxicillin
arm group type: Active Comparator
description: Amoxicillin 15mg/kg tds for 5 days
intervention type: Drug
intervention name: Odontopaste®
description: Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste® will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
arm group label: Intra-canal Odontopaste®
other name: Zinc Oxide based endodontic dressing
intervention type: Drug
intervention name: Pulpdent
description: Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
arm group label: Intra-canal Pulpdent
other name: Calcium hydroxide endodontic paste
intervention type: Drug
intervention name: Amoxicillin
description: Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days
arm group label: Oral Amoxicillin
other name: Amoxycillin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 11 Years
healthy volunteers: No
last name: Shani Ann Mani Dr
role: Principal Investigator
affiliation: Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
last name: Syarida Hasnur Dr
role: Principal Investigator
affiliation: Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya
last name: Lily Azura Shoaib Dr
role: Principal Investigator
affiliation: Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
facility: 
country: Malaysia
url: http://pdfs.semanticscholar.org/2e49/67ff2f0a06e4b4707d3f0b1436d7b437d91f.pdf
description: Intra Canal Treatments for Clinical Success and Patient Comfort
url: http://www.aae.org/specialty/wp-content/uploads/sites/2/2017/06/aae_systemic-antibiotics.pdf
description: American Association of Endodontics (AAE) Guidance on the Use of Systemic Antibiotics in Endodontics
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PMID: 28855834
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Dr. Shani Ann Mani
investigator title: Principal Investigator
mesh term: Abscess
mesh term: Periapical Abscess
mesh term: Amoxicillin
mesh term: Zinc Oxide
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