Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

May 17, 2023 updated by: Ahmad Elheeny

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Simvastatin
pulpotomy of immature permanent teeth
Other Names:
  • Mineral Trioxide Aggregate
Experimental: Mineral Trioxide Aggregate
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
Drug: Simvastatin
pulpotomy of immature permanent teeth
Other Names:
  • Mineral Trioxide Aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of pain
Time Frame: one year
clinical assessment
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentin wall thickness
Time Frame: 18 months
radiographic assessment
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmad Elheeny

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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