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Regenerative Endodontic Treatment of Traumatised Teeth

NCT03045185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-02-08

No results posted yet for this study

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

Interventions

PROCEDURE

RET using Ciprofloxacin 100mg, and Metronidazole 100mg.

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.

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Hani Nazzal, BDS, PhD · University of Leeds, School of Dentistry, Paediatric Dentistry Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2015-01-01
Completion
2017-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03045185 on ClinicalTrials.gov