The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.

Phase 2

Active, not recruiting

• Conditions: Revascularization of Immature Young Permenant Teeth
• Interventions: Biological: Revascularization of Immature Young Permenant Teeth

• Registration Number: NCT06630156
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2022-08-21
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2024-11-21
• Study Completion: 2024-12-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-MTA revascularization	Revascularization of Immature Young Permenant Teeth	-
Total Fill biocearmic root repair material revascularization	Revascularization of Immature Young Permenant Teeth	-

Primary Outcome Measures

Name	Time	Method
radiographic parameters	baseline, 3, 6, and 12 months after treatment	continued root lengthening and thickening of the dentinal walls in mm

Trial Locations

Locations (1)

faculty of dental medicine, Al-Azhar university; 🇪🇬 Assiut, Egypt