Clinical trial NCT06630156: The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
Official title: Clinical and Radiographic Evaluation of Bioceramic Root Repair Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Revascularization of Immature Young Permenant Teeth
Keywords: Revascularization
Bio MTA
Total Fill biocearmic root repair material
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients selected in this study were randomly divided into 2 groups:

1. Group A: 14 teeth were disinfected by triple paste and treated by Bio-MTA.
2. Group A: 14 teeth were disinfected by triple paste and treated by a Total Fill biocearmic root repair.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: radiographic parameters
timeFrame: baseline, 3, 6, and 12 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of dental medicine, Al-Azhar university
Study officials:
affiliation: Faculty of Dental Medicine, Al- Azhar University, Assuit, Egypt
name: Reda Mohammed Elsayed, assistant lecturer
role: PRINCIPAL_INVESTIGATOR
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