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

Tanta University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pulpotomy of Young Permanent Molars

Treatments: Drug: Mineral Tri-Oxide Aggregate; Drug: human treated dentin matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT06116695

11-21-1

Details and patient eligibility

About

Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA.

Full 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 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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

human-treated dentin matrix

Experimental group

Description:

drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix

Treatment:

Drug: human treated dentin matrix

mineral tri oxide aggregate

Placebo Comparator group

Description:

Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control

Treatment:

Drug: Mineral Tri-Oxide Aggregate