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

A

Al-Azhar University

Status and phase

Active, not recruiting
Phase 2

Conditions

Revascularization of Immature Young Permenant Teeth

Treatments

Biological: Revascularization of Immature Young Permenant Teeth

Study type

Interventional

Funder types

Other

Identifiers

NCT06630156
Treatment of immature teeth

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

7 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Bio-MTA revascularization
Active Comparator group
Treatment:
Biological: Revascularization of Immature Young Permenant Teeth
Total Fill biocearmic root repair material revascularization
Active Comparator group
Treatment:
Biological: Revascularization of Immature Young Permenant Teeth

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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