Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth

March 14, 2024 updated by: Shaimaa Shaban Mohamed El-desouky, Tanta University

Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial

Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: mohamed ghaly, lecturer
  • Phone Number: 01098472899

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 6624033
        • Recruiting
        • Tanta University
        • Contact:
        • Contact:
          • mohamed ghaly, PhD
          • Phone Number: 01098472899

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

No

Description

Inclusion Criteria:

  • nonvital immature permanent teeth as a consequence of trauma or dental caries
  • nonvital permanent teeth with radiographic evidence of immature root end development
  • clinically restorable teeth

Exclusion Criteria:

  • immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
  • Immature nonvital permanent teeth associated with developmental abnormalities.
  • Patients with a history of systemically debilitating diseases
  • unrestorable remaining crown structure

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MTA group
After the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
Procedure: Mineral trioxide aggregate
Apexification treatment was done with mineral trioxide aggregate
Experimental: Premixed Bioceramic Putty group
After the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
Procedure: Premixed Bioceramic Putty
Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
Time Frame: up to 12 months
The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
up to 12 months
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
Time Frame: at 6 and12 months follow up

The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption.

The apexification procedure will be radiographically unsuccessful if the apical lesion size increases.

The apexification procedure will be doubtful if the apical lesion size doesn't change
at 6 and12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the periapical index (PAI)
Time Frame: at 6 and12 months follow up
Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).
at 6 and12 months follow up

Collaborators and Investigators

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

Sponsor

Tanta University

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)

November 22, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # R-PED-11-23-3074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Periapical Periodontitis

Clinical Trials on Mineral trioxide aggregate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe