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

National University Health System, Singapore

Status and phase: Completed; Phase 2

Conditions: Infected Immature Permanent Teeth

Treatments: Drug: RET using non-setting Calcium Hydroxide; Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)

Study type: Interventional

Funder types: Other

Identifiers

NCT03327844

DSRB 2015/00612

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

RET using bi-Antibiotics

Active Comparator group

Description:

Interventions: Bi-antibiotics (Ciprofloxacin and Metronidazole) placed into the root canal during first treatment stage (disinfection stage)

Treatment:

Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)

RET using non-setting Calcium Hydroxide

Active Comparator group

Description:

Interventions: non-setting calcium hydroxide placed into the root canal during first treatment stage (disinfection stage)

Treatment:

Drug: RET using non-setting Calcium Hydroxide