Back to resultsSimvastatin Versus MTA in Pulpotomy of Immature Permanent Molars
Primary Purpose
Pulp Exposure, Dental
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Exposure, Dental
Eligibility Criteria
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
Sites / Locations
- Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
simvastatin
Mineral Trioxide Aggregate
Arm Description
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
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
Outcomes
Primary Outcome Measures
Presence or absence of pain
clinical assessment
Secondary Outcome Measures
Dentin wall thickness
radiographic assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05878158
Brief Title
Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars
Official Title
Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmad Elheeny
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Exposure, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
simvastatin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Mineral Trioxide Aggregate
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Mineral Trioxide Aggregate
Intervention Description
pulpotomy of immature permanent teeth
Primary Outcome Measure Information:
Title
Presence or absence of pain
Description
clinical assessment
Time Frame
one year
Secondary Outcome Measure Information:
Title
Dentin wall thickness
Description
radiographic assessment
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed aboalftooh, doctora
Phone
01092183998
Email
Doctormasmanlover22@gmail.com
Facility Information:
Facility Name
Faculty of Dentistry
City
Minya
ZIP/Postal Code
61111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Elheeny, PhD
Email
EG135.30708112400351@nies-edu.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars
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