Completed

NCT Number: NCT03327844

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

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.

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Key information

Conditions

Infected Immature Permanent Teeth

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University Hospital, Singapore

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

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.

Other names: 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.

Other names: Calcium hydroxide

Primary outcomes

Resolution periapical radiolucency (Clinical evaluation)

Time frame: 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)

Time frame: 18 months (reviews are at periodicity of 3 months)

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

Secondary outcomes

Continued root development (Radiographic evaluation)

Time frame: 18 months (reviews are at periodicity of 3 months)

Quantitative outcomes of lengths and thickness will be measured in millimeters (mm).
Discolouration of tooth

Time frame: 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))

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Collaborators

Health Promotion Board, Singapore
National University of Singapore

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Nov 1, 2017
Registry last updated: Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.