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Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

Sponsor
Ahmad Elheeny (Other)
Overall Status
Recruiting
CT.gov ID
NCT05878158
Collaborator
(none)
128
Enrollment
1
Location
2
Arms
17.1
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence or absence of pain [one year]

      clinical assessment

    Secondary Outcome Measures

    1. Dentin wall thickness [18 months]

      radiographic assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Minya Egypt 61111

    Sponsors and Collaborators

    • Ahmad Elheeny

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmad Elheeny, clinical professor, Minia University
    ClinicalTrials.gov Identifier:
    NCT05878158
    Other Study ID Numbers:
    • 300
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dental Pulp Exposure
    Simvastatin

    Study Results

    No Results Posted as of May 26, 2023