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

Not Applicable

Active, not recruiting

• Conditions: Pulpotomy of Young Permanent Molars
• Interventions: Drug: MTA group; Drug: Premixed Bioceramic material; Drug: Treated Dentin Matrix

• Registration Number: NCT07207382
• Lead Sponsor: Ain Shams University

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-20
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	MTA group	-
B	Premixed Bioceramic material	-
C	Treated Dentin Matrix	-

Primary Outcome Measures

Name	Time	Method
Clinical success	18 months	* Absence of pain related to the treated teeth, Including patient reported pain or sensitivity to percussion/palpation.; * No evidence of swelling of supporting soft tissue or presence of sinus tract.; * Absence of excessive mobility affecting treated teeth.
Radiographic success	18 months	* Radiographic criteria for success in terms of: * Progression of root formation; * No Internal or external root resorption.; * No Periapical or furcal radiolucency.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt