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

NCT07207382 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PED23-5D
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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)

Conditions

Pulpotomy of Young Permanent Molars

Keywords

young permanent; MTA; Pulpotomy; premixed bioceramic; treated dentin matrix

Outcome Measures

Primary Outcomes (2)

• Clinical success

  * 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.

  18 months

• Radiographic success

  * Radiographic criteria for success in terms of: * Progression of root formation * No Internal or external root resorption. * No Periapical or furcal radiolucency.

  18 months

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: MTA group

B

EXPERIMENTAL

Drug: Premixed Bioceramic material

C

EXPERIMENTAL

Drug: Treated Dentin Matrix

Interventions

MTA group DRUG

MTA group is considered the control group

A

Premixed Bioceramic material DRUG

Premixed Bioceramic material is test group B

B

Treated Dentin Matrix DRUG

Treated Dentin Matrix is test group C

C

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 6, 2025
• Study Start: February 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)