Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

Pulp Exposure, Dental Clinical Trial

Official title:

Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878158
• Other study ID #: 300
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2023
• Source: Minia University
• Contact: mohamed aboalftooh, doctora
• Phone: 01092183998
• Email: Doctormasmanlover22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Exposure
• Pulp Exposure, Dental

Intervention

Drug:
• Simvastatin
pulpotomy of immature permanent teeth

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Elheeny

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of pain	clinical assessment	one year
Secondary	Dentin wall thickness	radiographic assessment	18 months