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

NCT03327844 | Completed Phase 2 DMC

• 1 other identifier: DSRB 2015/00612
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Infected Immature Permanent Teeth

Keywords

Regenerative Endodontic Therapy; Infected immature permanent teeth

Outcome Measures

Primary Outcomes (2)

• Resolution periapical radiolucency (Clinical evaluation)

  Clinical evaluation: Presence/Absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.)

  18 months (reviews are at periodicity of 3 months)

• Resolution periapical radiolucency (Radiographic evaluation)

  Size of periapical lesion will be graded using Periapical Index (PAI)

  18 months (reviews are at periodicity of 3 months)

Secondary Outcomes (4)

• Continued root development (Radiographic evaluation)

  18 months (reviews are at periodicity of 3 months)

• Discolouration of tooth

  18 months (reviews are at periodicity of 3 months)

• Patient reported outcomes (Perceived oral health-related quality of life (OHRQL))

  18 months (reviews are at periodicity of 3 months)

• Patient reported outcomes (Quantitative pain rating)

  18 months (reviews are at periodicity of 3 months)

Study Arms (2)

RET using bi-Antibiotics

ACTIVE COMPARATOR

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

Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)

RET using non-setting Calcium Hydroxide

ACTIVE COMPARATOR

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

Drug: RET using non-setting Calcium Hydroxide

Interventions

RET using antibiotics (Ciprofloxacin and Metronidazole) DRUG

RET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.

Also known as: Bi-Antibiotics

RET using bi-Antibiotics

RET using non-setting Calcium Hydroxide DRUG

First Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.

Also known as: Calcium hydroxide

RET using non-setting Calcium Hydroxide

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6-16 years of age
• Patients who are fit and healthy or with American Society of Anesthesiologists (ASA) 1 or ASA 2 medical conditions
• Patients with cooperation level that would allow treatment under local analgesia, application of rubber dam isolation and taking of intraoral radiographs.
• 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)
• 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).

You may not qualify if:

• Patients aged \> 16 years of age.
• Patient with known allergies to Ciprofloxacin (or any fluoroquinolones class of antibiotics) or metronidazole antibiotics.
• Patients with medical conditions and/or receiving medications that would affect:
• Their body's ability to heal e.g. Diabetes; or
• Their ability to clot efficiently, e.g. Haemophilia
• Patients with risk of developing infective endocarditis or immune compromised patients.
• 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).
• Impacted or horizontally tilted teeth.
• 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.
• Uncooperative patients, or those unable to cope with treatment under local anaesthesia, rubber dam isolation and taking of intraoral radiographs.

Sponsors & Collaborators

• National University Health System, Singapore: lead
• National University of Singapore: collaborator
• Health Promotion Board, Singapore: collaborator

Study Sites (2)

School Dental Service, Health Promotion Board

Singapore, 168937, Singapore

Location

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Interventions

Ciprofloxacin; Metronidazole; Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Huei Jinn Tong

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: November 1, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)