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

NCT03761264 | Completed Phase 2 FDA Drug

• 1 other identifier: RP053A-17HTM
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentoalveolar Abscess

Keywords

Odontogenic Infections; Paediatric Patients; Local Antimicrobials; Systemic Antimicrobials; Dentoalveolar Abscess; Apical Dentoalveolar Abscess; Periapical Abscess; Suppurative Periapical Periodontitis

Outcome Measures

Primary Outcomes (10)

• Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7

  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.

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7

  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.

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7

  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.

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Temperature Score at Days 3, 5 or 7

  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)

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Trismus Score at Days 3, 5 or 7

  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).

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Percussion Score at Days 3, 5 or 7

  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.

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Fistula Score at Days 3, 5 or 7

  Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula

  Baseline, Days 3, 5 or 7

• Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7

  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.

  Baseline, Days 3, 5 or 7

• Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7

  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.

  Baseline, Day 5 or Day 7

• Mean change of ECOHIS scores from baseline and at Day 5 or Day 7

  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.

  Baseline, Day 5 or Day 7

Secondary Outcomes (1)

• Quantification of Individual Target Species

  First 2 Months of Study

Study Arms (3)

Intra-canal Odontopaste®

EXPERIMENTAL

Single visit placement of Odontopaste®

Drug: Odontopaste®

Intra-canal Pulpdent

ACTIVE COMPARATOR

Single visit placement of Pulpdent

Drug: Pulpdent

Oral Amoxicillin

ACTIVE COMPARATOR

Amoxicillin 15mg/kg tds for 5 days

Drug: Amoxicillin

Interventions

Odontopaste® 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.

Also known as: Zinc Oxide based endodontic dressing

Intra-canal Odontopaste®

Pulpdent 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.

Also known as: Calcium hydroxide endodontic paste

Intra-canal Pulpdent

Amoxicillin 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

Also known as: Amoxycillin

Oral Amoxicillin

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (19)

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Related Links

• Intra Canal Treatments for Clinical Success and Patient Comfort
• American Association of Endodontics (AAE) Guidance on the Use of Systemic Antibiotics in Endodontics
• The early childhood oral health impact scale (ECOHIS): Assessment tool in oral health related quality of life
• Bacteriology of Infected Deciduous Root Canal -A Review

MeSH Terms

Conditions

Periapical Abscess

Interventions

Pulpdent; Amoxicillin

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shani Ann Mani Dr

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

  PRINCIPAL INVESTIGATOR

• Syarida Hasnur Dr

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

  PRINCIPAL INVESTIGATOR

• Lily Azura Shoaib Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: September 18, 2018
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

MY (1)