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

nora mostafa mohammed abo shanady20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dentin Bridge

Interventions

human treated dentin matrixDRUG

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

Mineral Trioxide AggregateDRUG

mineral trioxide aggregate was used as control

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Tanta University

Tanta, El Gharbia, Egypt

Outcomes

Primary Outcomes

clinical outcome

patient reported pain or tenderness on palpation or percussion

Time frame: 18 months

clinical outcome

patient/ clinician observed swelling or sinus tract observation

Time frame: 18 months

clinical outcome

tooth mobility clinically assessed by grades

Time frame: 18 months

radiographic outcomes

radicular changes assessed by clinician from digital periapical radiograph

Time frame: 18 months

radiographic outcomes

interradicular changes assessed by clinician from digital periapical radiograph

Time frame: 18 months

radiographic outcomes

peri-radicular changes assessed by clinician from digital periapical radiograph

Time frame: 18 months

tomographic evaluation

evidence of continuity of root development measured from cone beam computed tomography

Time frame: 18 months

Data from ClinicalTrials.gov

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