Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant

January 4, 2025 updated by: Nourhan Yasser Yousef Mohamed, Cairo University

Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant Following Partial Pulpectomy in Primary Molars: A Randomized Clinical Trial

To evaluate the antimicrobial potency of Garlic Lemon extract irrigant versus physiological saline irrigant following partial pulpectomy in primary molars.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pulpectomy is a suitable treatment of primary teeth with irreversible pulpitis, necrosis, or periodontitis due to caries or trauma. Due to the complex nature of the deciduous root canal system makes total removal of necrotic tissue by instrumentation alone impossible. Therefore, irrigation is a replenishing step to create a disinfectant atmosphere inside the root canal.

A variety of antiseptic and antibacterial irrigating solutions have been used such as (NaOCl), (CHX), and (EDTA). Due to their adverse effects, safety issues and cytotoxic reactions, Herbal products can be an alternative to these irrigants based on their previous history in medical field.

Herbal extracts such as garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).However, there is no studies have been performed to assess the combination of Garlic-lemon extract as an irrigant in deciduous molars.

Study Type

Interventional

Enrollment (Estimated)

38

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

Study Contact Backup

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. The children's age range from four to seven years from both sexes.
  2. Presence of localized swelling, sinus and pain on percussion which indicate non vital pulp.
  3. Presence of periapical and furcation radiolucency in periapical radiograph.
  4. Absence of history of systemic disease which would contraindicate pulp therapy e.g. infective endocarditis.
  5. No previous history of antibiotics administration or last dose was taken from at least two weeks.

Exclusion Criteria:

  1. Presence of advanced physiologic or pathologic root resorption in X-ray.
  2. Uncooperative children.
  3. Teeth with unrestorable crowns.
  4. Teeth with abnormal anatomy and calcified canals.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Garlic-Lemon Extract irrigant

garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).
Combination product: Garlic-Lemon Extract irrigant

garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).
Active Comparator: physiological saline irrigant
Normal saline solution exhibits no adverse effects on the developing successors; Serves primarily to facilitate root canal cleaning during the irrigation process, in comparison to other commercial synthetic irrigants such as Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), Ethylenediamine tetra acetic acid (EDTA) which exhibit potential side effects and cytotoxic reactions (Sayadizadeh et al., 2019).
Other: physiological saline
Normal saline solution exhibits no adverse effects on the developing successors; Serves primarily to facilitate root canal cleaning during the irrigation process, in comparison to other commercial synthetic irrigants such as Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), Ethylenediamine tetra acetic acid (EDTA) which exhibit potential side effects and cytotoxic reactions (Sayadizadeh et al., 2019).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial count
Time Frame: pre and after irrigation within the same visit
colony forming unit (CFU) quantitative measure
pre and after irrigation within the same visit

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Rasha M Hatem, Associate Professor, Pediatric Department, Faculty of Dentistry, Cairo University.
  • Study Director: Samaa S Hanafy, Lecturer, Pediatric Department, Faculty of Dentistry, Cairo University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

December 29, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU 30/12/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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