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

Phase 1

Completed

• Conditions: Pulpotomy of Young Permanent Molars
• Interventions: Drug: Mineral Tri-Oxide Aggregate; Drug: human treated dentin matrix

• Registration Number: NCT06116695
• Lead Sponsor: Tanta University

Brief Summary

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

Study Timeline

• Study Start: 2022-01-18
• Primary Completion: 2023-06-18
• Study Completion: 2023-10-18
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mineral tri oxide aggregate	Mineral Tri-Oxide Aggregate	Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control
human-treated dentin matrix	human treated dentin matrix	drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix

Primary Outcome Measures

Name	Time	Method
clinical outcomes	18 months	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
Tomographic outcomes	18 months	Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt