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.
Overview
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.
Full Title of Study: “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.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: October 2022
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 .
Interventions
- Drug: Allium Sativum Oil
- Garlic oil Captain Company (CAP-PHARM)
- Drug: Mineral Tri-Oxide Aggregate
- ProRoot MTA, Dentsply
Arms, Groups and Cohorts
- 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 .
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Clinical effectiveness
- Time Frame: 1 year follow up
- clinical effectiveness will be measured by intraoral examination and radiographic assessment
Secondary Measures
- Cost-effectiveness
- Time Frame: 1 year follow up
- cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 5 Years
Maximum Age: 7 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Cairo University
- Provider of Information About this Clinical Study
- Principal Investigator: Lobna Magdy, Researcher – Cairo University
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.