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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07207382
Enrollment
69
Registered
2025-10-06
Start date
2024-02-20
Completion date
2026-07-01
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpotomy of Young Permanent Molars

Keywords

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

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)

Interventions

MTA group is considered the control group

DRUGPremixed Bioceramic material

Premixed Bioceramic material is test group B

DRUGTreated Dentin Matrix

Treated Dentin Matrix is test group C

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical success18 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 success18 months* Radiographic criteria for success in terms of: * Progression of root formation * No Internal or external root resorption. * No Periapical or furcal radiolucency.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026