Clinical And Cost- Effectiveness of Allium Sativum Oil (Garlic Oil ) Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.

August 19, 2021 updated by: Lobna Magdy, Cairo University

Clinical And Cost- Effectiveness of Allium Sativum Oil Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.

Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the most challenging subjects in paediatric dentistry is choosing the ideal pulp medication material that has the required properties such as preserving the vitality of the remaining intact pulp and stimulating its repair. This material should prevent pathological root resorption.Clinical and cost effectiveness trials from different countries are useful to determine which medicament should be advocated in which economic setting . Alternative pulpotomy materials clinically effective as MTA but with lower cost should be studied .

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2
  • Phase 3

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

5 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apparently healthy children aged from 5- 7 years.
  • Children not having antibiotics in the past 14 days.
  • Cooperative children.
  • Children are having at least two carious asymptomatic second primary molars.

Exclusion Criteria:

  • Uncooperative children.
  • Immunocompromised children.
  • Children with clinical or radiographic symptoms

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: Allium sativum oil
The pulp stumps of the molars are dressed with a cotton pellet that is made damp with Allium Sativum oil for 1 min .
Drug: Allium Sativum Oil
Garlic oil Captain Company (CAP-PHARM)
Other Names:
  • Garlic oil
Active Comparator: Mineral Trioxide Aggregate
The material will be prepared according to the manufacturer's instructions , applied to the pulp chamber and a moistened cotton pellet was placed over the MTA paste to allow the material to set.
Drug: Mineral Tri-Oxide Aggregate
ProRoot MTA, Dentsply
Other Names:
  • MTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effectiveness
Time Frame: 1 year follow up
clinical effectiveness will be measured by intraoral examination and radiographic assessment
1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 1 year follow up
cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER)
1 year follow up

Collaborators and Investigators

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

Sponsor

Cairo 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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lobnamagdy128

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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