Systemic and Local Antimicrobials in the Management of Dental Abscess in Children

NCT ID: NCT03761264

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2020-02-13

Brief 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.

Conditions

Dentoalveolar Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intra-canal Odontopaste®

Single visit placement of Odontopaste®

Group Type: EXPERIMENTAL

Odontopaste®

Intervention Type: DRUG

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.

Intra-canal Pulpdent

Single visit placement of Pulpdent

Group Type: ACTIVE_COMPARATOR

Pulpdent

Intervention Type: DRUG

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.

Oral Amoxicillin

Amoxicillin 15mg/kg tds for 5 days

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

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

Interventions

Odontopaste®

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.

Intervention Type: DRUG

Pulpdent

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.

Intervention Type: DRUG

Amoxicillin

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

Intervention Type: DRUG

Other Intervention Names

Zinc Oxide based endodontic dressing; Calcium hydroxide endodontic paste; Amoxycillin

Eligibility Criteria

Inclusion Criteria

• Patients presenting with acute odontogenic infections on primary teeth with evidence of intra-oral / extra- oral swelling and pus discharge
• Absence of any systemic disease
• Age group between 3-11 years
• Malaysian citizen

Exclusion Criteria

• Patients taking antibiotics 30 days prior to their attendance to the department
• Presence of any systemic disease
• Patients with cellulitis
• Patients suffering from spreading odontogenic infections which require hospitalization or immediate IV antibiotic treatment
• Tooth with poor prognosis for extraction
• Extensively resorbed roots (> 2/3rd)
• Patients allergic or resistance to amoxicillin
• Non-Malaysian citizen

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shani Ann Mani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shani Ann Mani Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya

Syarida Hasnur Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya

Lily Azura Shoaib Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya

Locations

University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://pdfs.semanticscholar.org/2e49/67ff2f0a06e4b4707d3f0b1436d7b437d91f.pdf

Intra Canal Treatments for Clinical Success and Patient Comfort

http://www.aae.org/specialty/wp-content/uploads/sites/2/2017/06/aae_systemic-antibiotics.pdf

American Association of Endodontics (AAE) Guidance on the Use of Systemic Antibiotics in Endodontics

http://www.researchgate.net/publication/325111490_The_early_childhood_oral_health_impact_scale_ECOHIS_Assessment_tool_in_oral_health_related_quality_of_life

The early childhood oral health impact scale (ECOHIS): Assessment tool in oral health related quality of life

Other Identifiers

RP053A-17HTM

Identifier Type: -

Identifier Source: org_study_id