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

October 10, 2024 updated by: Reda Mohammed Mohammed Elsayed, Al-Azhar University

Clinical and Radiographic Evaluation of Bioceramic Root Repair 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Dental Medicine, Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bio-MTA revascularization
Biological: Revascularization of Immature Young Permenant Teeth

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
Active Comparator: Total Fill biocearmic root repair material revascularization
Biological: Revascularization of Immature Young Permenant Teeth

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic parameters
Time Frame: baseline, 3, 6, and 12 months after treatment
continued root lengthening and thickening of the dentinal walls in mm
baseline, 3, 6, and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Reda Mohammed Elsayed, assistant lecturer, Faculty of Dental Medicine, Al- Azhar University, Assuit, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2022

Primary Completion (Estimated)

November 21, 2024

Study Completion (Estimated)

December 21, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Treatment of immature teeth

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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