Systemic and Local Antimicrobials in the Management of Dental Abscess in Children
Condition: Dentoalveolar Abscess
MeSH terms: Abscess; Periapical Abscess
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Odontopaste®; Pulpdent; Amoxicillin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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
Other intervention name(s): Zinc Oxide based endodontic dressing; Calcium hydroxide endodontic paste; Amoxycillin
Intervention MeSH terms: Amoxicillin; Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Odontogenic Infections; Paediatric Patients; Local Antimicrobials; Systemic Antimicrobials; Dentoalveolar Abscess; Apical Dentoalveolar Abscess; Periapical Abscess; Suppurative Periapical Periodontitis