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

Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05830695
Enrollment
20
Registered
2023-04-26
Start date
2022-01-18
Completion date
2023-03-31
Last updated
2024-07-30

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

Conditions

Dentin Bridge

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.

Interventions

human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis

DRUGMineral Trioxide Aggregate

mineral trioxide aggregate was used as control

Sponsors

nora mostafa mohammed abo shanady
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical outcome18 monthspatient reported pain or tenderness on palpation or percussion
radiographic outcomes18 monthsradicular changes assessed by clinician from digital periapical radiograph
tomographic evaluation18 monthsevidence of continuity of root development measured from cone beam computed tomography

Countries

Egypt

Outcome results

None listed

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