Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

Phase 1

Completed

• Conditions: Dentin Bridge
• Interventions: Drug: human treated dentin matrix; Drug: Mineral Trioxide Aggregate

• Registration Number: NCT05830695
• Lead Sponsor: nora mostafa mohammed abo shanady

Brief Summary

Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.

Detailed Description

The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:

Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.

Study Timeline

• Study Start: 2022-01-18
• Primary Completion: 2022-07-18
• Study Completion: 2023-03-31
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-23
• Study First Posted: 2023-04-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Bilateral immature permanent mandibular first molars with deep carious lesions.
2. Positive response to pulp testing.
3. Normal radiographic appearance.
4. Healthy children without any systemic disease that interferes with pulp healing.
5. Patient and parent cooperation.

Exclusion Criteria

1. Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
2. Presence of periapical lesion, external or internal root resorption.
3. Carious furcation involvement.
4. Dystrophic calcification of the pulp.
5. Non restorable tooth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
human treated dentin matrix	human treated dentin matrix	study group
mineral tri oxide aggregate	Mineral Trioxide Aggregate	control group

Primary Outcome Measures

Name	Time	Method
clinical outcome	18 months	tooth mobility clinically assessed by grades
radiographic outcomes	18 months	peri-radicular changes assessed by clinician from digital periapical radiograph
tomographic evaluation	18 months	evidence of continuity of root development measured from cone beam computed tomography

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt