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

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

Detailed Description
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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.

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

Conditions
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Dentin Bridge

Intervention / Treatment
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* Drug: human treated dentin matrix
* Drug: Mineral Trioxide Aggregate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral immature permanent mandibular first molars with deep carious lesions. Positive response to pulp testing. Normal radiographic appearance. Healthy children without any systemic disease that interferes with pulp healing. Patient and parent cooperation. Exclusion Criteria: Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract. Presence of periapical lesion, external or internal root resorption. Carious furcation involvement. Dystrophic calcification of the pulp. Non restorable tooth.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: human treated dentin matrix<br>study group | Drug: human treated dentin matrix<br>* human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis<br>* Other names: human partially demineralized treated dentin matrix;|
| Experimental: mineral tri oxide aggregate<br>control group | Drug: Mineral Trioxide Aggregate<br>* mineral trioxide aggregate was used as control<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome | patient reported pain or tenderness on palpation or percussion | 18 months | 
| clinical outcome | patient/ clinician observed swelling or sinus tract observation | 18 months | 
| clinical outcome | tooth mobility clinically assessed by grades | 18 months | 
| radiographic outcomes | radicular changes assessed by clinician from digital periapical radiograph | 18 months | 
| radiographic outcomes | interradicular changes assessed by clinician from digital periapical radiograph | 18 months | 
| radiographic outcomes | peri-radicular changes assessed by clinician from digital periapical radiograph | 18 months | 
| tomographic evaluation | evidence of continuity of root development measured from cone beam computed tomography | 18 months |