Clinical trial NCT03327844: Regenerative Endodontic Therapy (RET) for the Management of Immature Non-vital Permanent Teeth in Children
Official title: Regenerative Endodontic Therapy (RET) Using Antibiotic Pastes or Calcium Hydroxide Disinfection for the Management of Immature Non-vital Permanent Teeth in Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infected Immature Permanent Teeth
Keywords: Regenerative Endodontic Therapy
Infected immature permanent teeth
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: Health Promotion Board, Singapore
First posted: 2017-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Resolution periapical radiolucency (Clinical evaluation)
timeFrame: 18 months (reviews are at periodicity of 3 months)
measure: Resolution periapical radiolucency (Radiographic evaluation)
timeFrame: 18 months (reviews are at periodicity of 3 months)
Secondary outcomes:
measure: Continued root development (Radiographic evaluation)
timeFrame: 18 months (reviews are at periodicity of 3 months)
measure: Discolouration of tooth
timeFrame: 18 months (reviews are at periodicity of 3 months)
measure: Patient reported outcomes (Perceived oral health-related quality of life (OHRQL))
timeFrame: 18 months (reviews are at periodicity of 3 months)
measure: Patient reported outcomes (Quantitative pain rating)
timeFrame: 18 months (reviews are at periodicity of 3 months)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: School Dental Service, Health Promotion Board
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System
name: Huei Jinn Tong
role: PRINCIPAL_INVESTIGATOR
References: