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.

NCT04903808 | Unknown Phase 2 DMC

• 1 other identifier: Lobnamagdy128
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carious Primary Molars

Keywords

Allium sativum oil; MTA; pulpotomy

Outcome Measures

Primary Outcomes (1)

• Clinical effectiveness

  clinical effectiveness will be measured by intraoral examination and radiographic assessment

  1 year follow up

Secondary Outcomes (1)

• Cost-effectiveness

  1 year follow up

Study Arms (2)

Allium sativum oil

EXPERIMENTAL

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

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

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

Interventions

Allium Sativum Oil DRUG

Garlic oil Captain Company (CAP-PHARM)

Also known as: Garlic oil

Allium sativum oil

Mineral Tri-Oxide Aggregate DRUG

ProRoot MTA, Dentsply

Also known as: MTA

Mineral Trioxide Aggregate

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

allyl sulfide; TheraCal; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and outcome assessor will be blinded (double blind study )
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: It is a double-blinded randomised clinical trial with equal randomisation parallel design with allocation ratio 1:1

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 27, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08