Skip to main content
Clinical Trials/NCT06630156
NCT06630156
Active, not recruiting
Phase 2

Clinical and Radiographic Evaluation of Bioceramic Root Repair Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.

Al-Azhar University1 site in 1 country28 target enrollmentAugust 21, 2022

Overview

Phase
Phase 2
Intervention
Revascularization of Immature Young Permenant Teeth
Conditions
Revascularization of Immature Young Permenant Teeth
Sponsor
Al-Azhar University
Enrollment
28
Locations
1
Primary Endpoint
radiographic parameters
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:

  1. Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
  2. Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.

Detailed Description

In a young permanent tooth with pulp necrosis and apical pathosis, routine endodontic treatment may not be possible due to the immature apex it possesses. Newer methods based on the principles of revascularization and regeneration have been tried and found to be much better than the traditional methods of apexification since it helps in physiological root maturation, unlike traditional methods which result in only artificial barrier formation without root lengthening. Revascularization is a new treatment method for immature necrotic permanent teeth. Indeed, it would provide, after treatment, a vital tooth that would be able to complete its root maturation. Three key requirements for a successful revascularization are: (a) Root canal disinfection; (b) matrix inside the canal for growth of tissue (scaffold); and (c) a tight seal access filling. Bio MTA was introduced to overcome some of the drawbacks of MTA such as handling properties and long setting time. Bio MTA has a faster setting time with good handling characteristics and biological properties. Calcium silicate based restorative cements were formulated using different calcium compounds such as calcium hydroxide, calcium oxide, calcium phosphate, calcium sulfate, calcium silicate, and calcium carbonate in combination with zirconium. The mixed cement comprises water-soluble calcium and phosphate and immediately forms hydroxyapatite during and after setting. A Total Fill biocearmic root repair material which is calcium silicate-based cement was developed with excellent handling properties as it is supplied in premixed packages (putty) that do not require preparation before use. It is mainly composed of calcium silicate, monobasic calcium phosphate, calcium hydroxide, and zirconium oxide. It has antibacterial and antifungal activities. It is claimed that the material is biocompatible with human periodontal tissues.

Registry
clinicaltrials.gov
Start Date
August 21, 2022
End Date
December 21, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reda Mohammed Mohammed Elsayed

assistant lecturer

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Child with an age ranged from (7-12) year from both sexes.
  • Patient and parent cooperation.
  • Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis.
  • Patient is not taking antibiotic and has not taken for the past 2 weeks.
  • Restorable teeth.
  • The root to crown ratio should be at least 1:1.

Exclusion Criteria

  • Patients allergic to any drug used in this RCT.
  • Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children).
  • Tooth with vital pulp or complete root formation.
  • Teeth with draining sinus or periodontal weak mobile teeth.
  • Teeth with internal or external root resorption.
  • Tooth with root fracture.

Arms & Interventions

Bio-MTA revascularization

Intervention: Revascularization of Immature Young Permenant Teeth

Total Fill biocearmic root repair material revascularization

Intervention: Revascularization of Immature Young Permenant Teeth

Outcomes

Primary Outcomes

radiographic parameters

Time Frame: baseline, 3, 6, and 12 months after treatment

continued root lengthening and thickening of the dentinal walls in mm

Study Sites (1)

Loading locations...

Similar Trials