Regenerative Endodontic Therapy (RET) for the Management of Immature Non-vital Permanent Teeth in Children

Phase 2

Completed

• Conditions: Infected Immature Permanent Teeth
• Interventions: Drug: RET using non-setting Calcium Hydroxide; Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)

• Registration Number: NCT03327844
• Lead Sponsor: National University Health System, Singapore

Brief Summary

This study evaluates the efficacy of Antibiotic pastes or Calcium hydroxide disinfection on healing of periapical pathology and continued root development of infected non-vital immature permanent teeth in children.

In the test group regenerative endodontic therapy (RET) is performed with antibiotics as the disinfecting agent, in the control group RET is performed with Calcium Hydroxide as the disinfecting agent.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-11-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients aged 6-16 years of age

2. Patients who are fit and healthy or with American Society of Anesthesiologists (ASA) 1 or ASA 2 medical conditions

3. Patients with cooperation level that would allow treatment under local analgesia, application of rubber dam isolation and taking of intraoral radiographs.

4. Patients with permanent premolars that have incomplete root formation with an open apex of greater than 1mm width as observed radiographically and of single root canal morphology (22)

5. Patients with single rooted immature permanent premolars having one of the following pulpal and periapical diagnosis:

   a. Pulpal i. Necrotic pulp ii. Symptomatic and inflamed pulp not expected to heal. During attempted Cvek or cervical pulpotomy procedures, if the pulpal bleeding does not stop with direct pressure within 5 minutes, pulpectomy will be carried out and the patient will be recruited for RET procedures.

   b. Periapical i. Symptomatic apical periodontitis (with or without a radiographic apical lesion) ii. Asymptomatic apical periodontitis (with a radiographic apical lesion) iii. Acute apical abscess iv. Chronic apical abscess Teeth will be deemed non-vital if either are non-responsive to sensibility tests (i.e. Electric Pulp test and cold tests), and/or present with signs and symptoms of non-vitality (e.g. swelling and abscess).

Exclusion Criteria

1. Patients aged > 16 years of age.

2. Patient with known allergies to Ciprofloxacin (or any fluoroquinolones class of antibiotics) or metronidazole antibiotics.

3. Patients with medical conditions and/or receiving medications that would affect:

   1. Their body's ability to heal e.g. Diabetes; or
   2. Their ability to clot efficiently, e.g. Haemophilia

4. Patients with risk of developing infective endocarditis or immune compromised patients.

5. Patients with non-vital permanent premolars where root development is already deemed to be completed (i.e. foramen size of 0-1.0mm diameter as determined radiographically).

6. Impacted or horizontally tilted teeth.

7. Concurrent signs of irreversible pathological root resorption determined radiographically, e.g replacement or internal root resorption, which could otherwise affect the prognosis of the tooth.

8. Uncooperative patients, or those unable to cope with treatment under local anaesthesia, rubber dam isolation and taking of intraoral radiographs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RET using non-setting Calcium Hydroxide	RET using non-setting Calcium Hydroxide	Interventions: non-setting calcium hydroxide placed into the root canal during first treatment stage (disinfection stage)
RET using bi-Antibiotics	RET using antibiotics (Ciprofloxacin and Metronidazole)	Interventions: Bi-antibiotics (Ciprofloxacin and Metronidazole) placed into the root canal during first treatment stage (disinfection stage)

Primary Outcome Measures

Name	Time	Method
Resolution periapical radiolucency (Clinical evaluation)	18 months (reviews are at periodicity of 3 months)	Clinical evaluation: Presence/Absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.)
Resolution periapical radiolucency (Radiographic evaluation)	18 months (reviews are at periodicity of 3 months)	Size of periapical lesion will be graded using Periapical Index (PAI)

Secondary Outcome Measures

Name	Time	Method
Continued root development (Radiographic evaluation)	18 months (reviews are at periodicity of 3 months)	Quantitative outcomes of lengths and thickness will be measured in millimeters (mm).
Discolouration of tooth	18 months (reviews are at periodicity of 3 months)	Changes in tooth colour will be measured through assessment of photographs
Patient reported outcomes (Perceived oral health-related quality of life (OHRQL))	18 months (reviews are at periodicity of 3 months)	Oral health related quality of life will be evaluated using the validated questionnaire Child-Oral Impacts on daily performances (C-OIDP)
Patient reported outcomes (Quantitative pain rating)	18 months (reviews are at periodicity of 3 months)	Quantitative pain rating will be done using Faces Pain scale for children 12 years and below; and Numeric Rating scale (NRS) for children 13 years and above.; Faces Pain Scale (range: 0-10); higher scores indicate worse pain; Numeric Rating scale (range: 0-10; 0 - no pain, 1-3 - mild pain, 4-6 - moderate pain, 7-10 - severe pain); higher scores indicate worse pain

Trial Locations

Locations (2)

School Dental Service, Health Promotion Board; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore