Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

NCT ID: NCT05878158

Last Updated: 2023-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Pulp Exposure, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

pulpotomy of immature permanent teeth

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

pulpotomy of immature permanent teeth

Interventions

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Simvastatin

pulpotomy of immature permanent teeth

Intervention Type DRUG

Other Intervention Names

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Mineral Trioxide Aggregate

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmad Elheeny

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Elheeny

clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed aboalftooh, doctora

Role: CONTACT

01092183998

Facility Contacts

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Ahmad Elheeny, PhD

Role: primary

Other Identifiers

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300

Identifier Type: -

Identifier Source: org_study_id

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