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.

Phase 2

• Conditions: Carious Primary Molars
• Interventions: Drug: Allium Sativum Oil; Drug: Mineral Tri-Oxide Aggregate

• Registration Number: NCT04903808
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25
• Study Start: 2021-09
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allium sativum oil	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 .
Mineral Trioxide Aggregate	Mineral Tri-Oxide 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.

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness	1 year follow up	clinical effectiveness will be measured by intraoral examination and radiographic assessment

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	1 year follow up	cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER)