Garlic Oil As Root Filling Material in Primary Molars

March 18, 2025 updated by: Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University

Evaluation of Allium Sativum As Root Filling Material for Primary Molars Indicated for Non Vital Pulp Therapy: Randomized Clinical Trials

The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.

the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).

The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
  2. Presence of sinus tract.
  3. Periapical bone swelling.
  4. Continuous bleeding after amputation of the coronal pulp tissue.
  5. No pulp tissue remains when the pulp chamber is accessed.
  6. Pus discharges from the canal.
  7. Radiographically, only primary molars with at least two-thirds of the root length.
  8. Presence of inter-radicular or periapical radiolucency.

Exclusion Criteria:

1. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: garlic oil with zinc oxide group
Combination product: Garlic oil
garlic oil mixed with zinc oxid powder, as root canal filling material
Active Comparator: metapex group
Drug: Calcium Hydroxide, Iodoform, paste
Metapex as root canal filling materials
Other Names:
  • metapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical success rate
Time Frame: 3, 6,9,and 12 months
The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"
3, 6,9,and 12 months
Radio-graphic success
Time Frame: 6, and 12 month.
For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"
6, and 12 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 8, 2025

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

November 8, 2026

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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