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.

NCT ID: NCT04903808

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-10-31

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 .

Conditions

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Carious Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a double-blinded randomised clinical trial with equal randomisation parallel design with allocation ratio 1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
participants and outcome assessor will be blinded (double blind study )

Study Groups

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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 .

Group Type EXPERIMENTAL

Allium Sativum Oil

Intervention Type DRUG

Garlic oil Captain Company (CAP-PHARM)

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.

Group Type ACTIVE_COMPARATOR

Mineral Tri-Oxide Aggregate

Intervention Type DRUG

ProRoot MTA, Dentsply

Interventions

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Allium Sativum Oil

Garlic oil Captain Company (CAP-PHARM)

Intervention Type DRUG

Mineral Tri-Oxide Aggregate

ProRoot MTA, Dentsply

Intervention Type DRUG

Other Intervention Names

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Garlic oil MTA

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lobna Magdy

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Lobnamagdy128

Identifier Type: -

Identifier Source: org_study_id

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