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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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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.

Conditions
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Carious Primary Molars

Intervention / Treatment
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* Drug: Allium Sativum Oil
* Drug: Mineral Tri-Oxide Aggregate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a double-blinded randomised clinical trial with equal randomisation parallel design with allocation ratio 1:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allium sativum oil<br>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<br>* Garlic oil Captain Company (CAP-PHARM)<br>* Other names: Garlic oil;|
| Active Comparator: Mineral Trioxide Aggregate<br>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<br>* ProRoot MTA, Dentsply<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTA, Allium sativum oil, pulpotomy