Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2026-07-01

Brief Summary

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Statement of the problem:

Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities.

Biomimetic materials placement after performing pulp therapy is one of the important factors to determine healing of the pulp and continue root formation. In this study a novel material "Treated Dentin Matrix" is used in comparison to premixed bioceramic material and "Mineral Trioxide Aggregate" in pulpotomy of immature permanent molars.

The Aim of the study:

Is to assess the clinical and radiographic success of pulpotomized first permanent immature molars treated with three different Biomimetic materials (Treated Dentin Matrix, Premixed Bio-ceramic material and Mineral Trioxide Aggregate)

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Detailed Description

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Conditions

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Pulpotomy of Young Permanent Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

MTA group

Intervention Type DRUG

MTA group is considered the control group

B

Group Type EXPERIMENTAL

Premixed Bioceramic material

Intervention Type DRUG

Premixed Bioceramic material is test group B

C

Group Type EXPERIMENTAL

Treated Dentin Matrix

Intervention Type DRUG

Treated Dentin Matrix is test group C

Interventions

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MTA group

MTA group is considered the control group

Intervention Type DRUG

Premixed Bioceramic material

Premixed Bioceramic material is test group B

Intervention Type DRUG

Treated Dentin Matrix

Treated Dentin Matrix is test group C

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Children aged between 7 and 10 years-old.
2. Vital permanent first molars with deep caries lesion approaches the pulp without symptoms of irreversible pulpitis, with open apices in the radiograph.
3. Permanent first molars with pulpal exposure that occurred during caries excavation.
4. Incompletely formed roots

Exclusion Criteria

* (1) Teeth with signs and symptoms of chronic infection such as swelling and mobility. (2) Teeth with excessive bleeding from amputated radicular stumps (3) Teeth showing radiographic evidence of pathologic root resorption, inter-radicular bone loss, periapical pathology and calcifications in the canals. (4) Lack of patient/parent compliance and cooperation. (5)Children who are physically or mentally disabled or having any medical condition that will complicate the treatment

Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes