Regenerative Endodontic Treatment of Traumatised Teeth

NCT03045185 | Completed

• 1 other identifier: REC 12/YH0488
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative endodontic technique (RET) for the management of traumatised non-vital immature teeth in children. Methodology: This study aims to recruit 25-30 healthy children with traumatised non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments, clinical reviews and standardised radiographic exposures. Radiographic analysis will be carried out by two calibrated experienced clinicians. Standardised photographs will be taken at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised validated methodology.

Conditions

Tooth Injuries; Endodontically Treated Teeth

Keywords

Non Vital teeth; Traumatised teeth; Immature teeth; Regenerative Endodontics

Outcome Measures

Primary Outcomes (4)

• Change in root length

  Root length from cement enamel junction to radiographic apex measured over time

  Month 3, Month 9, Year 2, and year 3.

• Change in root dentinal wall width

  Root dentinal width measured radiographically at 2/3 root length over time

  Month 3, Month 9, Year 2, and year 3.

• Change in apical foramen width

  Apical foramen width measured radiographically over time

  Month 3, Month 9, Year 2, and year 3.

• Change in periodontal healing

  Absence of signs and symptoms of infection over time

  Month 3, Month 6, Month 9, Year 2, and year 3.

Secondary Outcomes (1)

• Change in crown Colour

  Month 3,Month 12, year 2, and year 3.

Study Arms (1)

Treatment Group

EXPERIMENTAL

RET using Ciprofloxacin 100mg, and Metronidazole 100mg.

Procedure: RET using Ciprofloxacin 100mg, and Metronidazole 100mg.

Interventions

RET using Ciprofloxacin 100mg, and Metronidazole 100mg. PROCEDURE

First Treatment Visit: Tooth isolation, access, pulp extirpation and root canal irrigation with 0.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the Bi antibiotic paste (mixture of Bi antibiotic paste (Ciprofloxacin 100mg and Metronidazole 100mg with sterile water). Sealing tooth access with glass ionomer cement. Second Treatment Visit: Tooth analgesia using plain local analgesics, isolatation and re-access as described above. Irrigation of root canal system using normal saline followed by paper point dying. Initiation of bleeding through insertion of a sterile 23-gauge needle with a length of 2 mm beyond the working length into the periapical tissues. Access sealed using Portland cement, followed by glass ionomer and then composite resin.

Treatment Group

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 an ASA1 or ASA2 medical conditions
• Patients with cooperation level that would allow treatment under local analgesia
• Patients with a traumatised permanent incisors, canines or premolars having at least one of the following:
• Necrotic or partially necrotic root canal systems.
• Periapical periodontitis/abscess.
• Sinus tract.
• Patients with permanent incisors, canines or premolars that have incomplete root formation with open apices.

You may not qualify if:

• Patient older than 16 year of age
• Patients allergic to Ciprofloxacin, Metronidazole.
• Patients with medical conditions and/or receiving medications that would affect patients' body's ability to heal such as diabetic patients or ability of the patients' blood to clot such as patients with Von Willebrand's disease.
• Patients with risk of developing infective endocarditis or immune compromised patients.
• Patients with non traumatised non-vital permanent incisors, canines or premolars where root development already deemed to be completed.
• No concurrent signs of other pathological root resorption, such as replacement root resorption, which could otherwise affect the prognosis of the tooth.
• Uncooperative patients.

Sponsors & Collaborators

• University of Leeds: lead

MeSH Terms

Conditions

Tooth Injuries; Tooth, Nonvital

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Dental Pulp Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hani Nazzal, BDS, PhD

  University of Leeds, School of Dentistry, Paediatric Dentistry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single group so no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective interventional uncontrolled trial

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 7, 2017
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share