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NCT Number: NCT06630156

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

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.

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Key information

Conditions

Revascularization of Immature Young Permenant Teeth

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

faculty of dental medicine, Al-Azhar university

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revascularization of Immature Young Permenant Teeth

Biological

An access cavity was prepared under rubber dam, isolation, root canal system disinfection was done without mechanical instrumentation. Subsequently, triple antibiotic paste was placed into the apical portion of the canal and filled to just below the CEJ. The access cavity was temporarily restored with glass ionomer.

4 weeks later, after reopening of the access, the antibiotic paste was gently flushed out of the canal with sterile normal saline. The root canal system was irrigated. A sterile #35 K-file will be introduced into the canal beyond the apical foramen using a push and pull motion to provoke bleeding from the periapical tissue. After bleeding control and formation of fresh blood clot, 3 mm of Bio (MTA) will be placed in Group A, 3 mm of Total Fill biocearmic root repair material will be placed in Group B after a moist cotton pellet was placed over the capping material and the access cavity will be sealed with G C

Primary outcomes

  1. radiographic parameters

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

    continued root lengthening and thickening of the dentinal walls in mm

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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