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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2024-12-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate

Intervention Type PROCEDURE

Apexification treatment was done with mineral trioxide aggregate

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.

Group Type EXPERIMENTAL

Premixed Bioceramic Putty

Intervention Type PROCEDURE

Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

Interventions

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Mineral trioxide aggregate

Apexification treatment was done with mineral trioxide aggregate

Intervention Type PROCEDURE

Premixed Bioceramic Putty

Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No