Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

Early Phase 1

Recruiting

• Conditions: Pulp Exposure, Dental
• Interventions: Drug: Simvastatin

• Registration Number: NCT05878158
• Lead Sponsor: Ahmad Elheeny

Brief Summary

the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars

Detailed Description

the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars for the following patients which include: Healthy children aged from 6 to 8 years who will be classified as Class I or II Children according to the American Society of Anaesthesiologists (ASA) will be included. Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26
• Primary Completion: 2024-01-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Healthy children aged from 6 to 8 years
• Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
• Deep carious lesions of the first permanent immature molars with signs & symptoms of reversible pulpitis will be included
• Normal radiographic findings and immature roots

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral Trioxide Aggregate	Simvastatin	Dental material It is a regenrative endodontic material prepared as apoweder that mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump
simvastatin	Simvastatin	Drug The drug powder will be mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump

Primary Outcome Measures

Name	Time	Method
Presence or absence of pain	one year	clinical assessment

Secondary Outcome Measures

Name	Time	Method
Dentin wall thickness	18 months	radiographic assessment

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Minya, Egypt