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

Ain Shams University

Status and phase: Active, not recruiting; Phase 3

Conditions: Pulpotomy of Young Permanent Molars

Treatments: Drug: Premixed Bioceramic material; Drug: MTA group; Drug: Treated Dentin Matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT07207382

PED23-5D

Details and patient eligibility

About

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)

Enrollment: 69 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 3 patient groups

A

Active Comparator group

Treatment:

Drug: MTA group

B

Experimental group

Treatment:

Drug: Premixed Bioceramic material

C

Experimental group

Treatment:

Drug: Treated Dentin Matrix