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

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