NCT05878158

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 2, 2023

Last Update Submit

May 17, 2023

Conditions

Pulp Exposure, Dental

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of pain

    clinical assessment

    one year

Secondary Outcomes (1)

  • Dentin wall thickness

    18 months

Study Arms (2)

simvastatin

ACTIVE COMPARATOR

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

Mineral Trioxide Aggregate

EXPERIMENTAL

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

Interventions

SimvastatinDRUG

pulpotomy of immature permanent teeth

Also known as: Mineral Trioxide Aggregate
Mineral Trioxide Aggregatesimvastatin

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Minya, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

Simvastatinmineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Central Study Contacts

mohamed aboalftooh, doctora

CONTACT

01092183998Doctormasmanlover22@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 26, 2023

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

September 1, 2024

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

EG(1)