Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761264
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Shani Ann Mani, University of Malaya

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.

Condition or disease Intervention/treatment Phase
Dentoalveolar Abscess Drug: Odontopaste® Drug: Pulpdent Drug: Amoxicillin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : February 13, 2020
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Antibiotics

Arm Intervention/treatment
Experimental: Intra-canal Odontopaste®
Single visit placement of Odontopaste®
Drug: 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.
Other Name: Zinc Oxide based endodontic dressing

Active Comparator: Intra-canal Pulpdent
Single visit placement of Pulpdent
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.
Other Name: Calcium hydroxide endodontic paste

Active Comparator: Oral Amoxicillin
Amoxicillin 15mg/kg tds for 5 days
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
Other Name: Amoxycillin




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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.

  4. Mean Change From Baseline in Temperature Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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)

  5. Mean Change From Baseline in Trismus Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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).

  6. Mean Change From Baseline in Percussion Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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.

  7. Mean Change From Baseline in Fistula Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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

  8. Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7 [ Time Frame: Baseline, 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.

  9. 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 ]
    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.

  10. Mean change of ECOHIS scores from baseline and at Day 5 or Day 7 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Quantification of Individual Target Species [ Time Frame: First 2 Months of Study ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761264


Locations
Layout table for location information
Malaysia
University of Malaya
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
Layout table for investigator information
Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Dr. Shani Ann Mani, University of Malaya:
Study Protocol  [PDF] September 18, 2018
Informed Consent Form  [PDF] September 18, 2018

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Dr. Shani Ann Mani, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT03761264    
Other Study ID Numbers: RP053A-17HTM
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Shani Ann Mani, University of Malaya:
Odontogenic Infections
Paediatric Patients
Local Antimicrobials
Systemic Antimicrobials
Dentoalveolar Abscess
Apical Dentoalveolar Abscess
Periapical Abscess
Suppurative Periapical Periodontitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Abscess
Periapical Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Periapical Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periodontitis
Amoxicillin
Zinc Oxide
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents