Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix

Study Overview
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Brief Summary
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Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus 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 pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows: Group I (Study group): 20 molars were treated with hTDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition. Tomographic evaluation was performed immediate postoperatively and at 18 months.

Official Title
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Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix Versus Mineral Trioxide Aggregate

Conditions
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Pulpotomy of Young Permanent Molars

Intervention / Treatment
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* Drug: human treated dentin matrix
* Drug: Mineral Tri-Oxide 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>drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix | 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;|
| Placebo Comparator: mineral tri oxide aggregate<br>Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control | Drug: Mineral Tri-Oxide Aggregate<br>* mineral trioxide aggregate was used as control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcomes | Absence of pain related to the treated teeth, including pain or sensitivity to percussion/palpation, No evidence of swelling or presence of a sinus tract, Absence of mobility affecting the treated teeth | 18 months | 
| Tomographic outcomes | Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura. | 18 months |