Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effect on Pulpotomy

November 16, 2024 updated by: sara nabil, Al-Azhar University

Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effectiveness in Pulpotomy of Primary Molars

Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Alazhar University

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

Yes

Description

Inclusion Criteria:

  • healthy patients with carious primary molars

Exclusion Criteria:

  • root resorption

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mta group
after pulpotomy the pulp stumps subgected to mta material
Procedure: Pulpotomy
Pulpotomy will be done for mta group
Procedure: extraction for histologic examination
after pulp therapy the teeth exrtracted for histologic examination
Experimental: Grape seed group
after pulpotomy the pulp stumps subjected to grape seed
Procedure: Pulpotomy
Pulpotomy will be done for mta group
Procedure: extraction for histologic examination
after pulp therapy the teeth exrtracted for histologic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate pain of the teeth
Time Frame: 6 months
The lack of any clinical indications of pulp degeneration, such as the history of spontaneous pain, pain on percussion, swelling, pathological mobility, or sinus tract
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absence of radiolucency
Time Frame: 6 months
No signs of periapical orfurcal radiolucency, widening of the periodontal ligament (PDL), or pathological root resorption (internal or external).
6 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

January 2, 2023

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

September 2, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

November 16, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC- PD-23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set

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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