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

NCT ID: NCT06759766

Last Updated: 2025-01-07

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Necrotic Primary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled clinical trial, parallel group, allocation ratio 1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The blinding of operator is not possible due to the nature of the material used. The clinical outcome assessor and statistician will be blinded in this study.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Garlic-Lemon Extract irrigant

Intervention Type COMBINATION_PRODUCT

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).

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).

Group Type ACTIVE_COMPARATOR

physiological saline

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type COMBINATION_PRODUCT

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 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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Nourhan Yasser Yousef Mohamed

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasha M Hatem, Associate Professor

Role: STUDY_DIRECTOR

Pediatric Department, Faculty of Dentistry, Cairo University.

Samaa S Hanafy, Lecturer

Role: STUDY_DIRECTOR

Pediatric Department, Faculty of Dentistry, Cairo University.

Central Contacts

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Nourhan Y Yousef, masters researcher

Role: CONTACT

00201066085773

Rasha M Hatem, Assoc.Prof.

Role: CONTACT

00201001670222

References

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Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.

Reference Type BACKGROUND
PMID: 31452953 (View on PubMed)

Salem, M. R., Taha, S., & Abd El Gwad, R. (2017). Evaluation Of Antimicrobial Efficacy Of Green Tea Extract Irrigant Versus Physiological Saline Following Root Canal Treatment Of Infected Primary Molars In A Group Of Egyptian Children: A Randomized Clinical Trial. Egyptian Dental Journal, 63(Issue 1 - January (Orthodontics, Pediatric & Preventive Dentistry)), 101-110.

Reference Type BACKGROUND

Shalan, H. M. (2023). Evaluation of Antimicrobial Efficiency of Herbal Irrigants of Pulpectomized Primary Teeth. Mansoura Journal of Dentistry, 10(2), 97-101.

Reference Type BACKGROUND

Siddique, R., Anjaneyulu, K., & Muralidharan, N. P. (2019). Antimicrobial efficacy of garlic-lemon in comparison with sodium hypochlorite against E. faecalis. J Clin Diagn Res, 13(1), 55-58.

Reference Type BACKGROUND

Siddique R, Ranjan M, Jose J, Srivastav A, Rajakeerthi R, Kamath A. Clinical Quantitative Antibacterial Potency of Garlic-Lemon Against Sodium Hypochlorite in Infected Root Canals: A Double-blinded, Randomized, Controlled Clinical Trial. J Int Soc Prev Community Dent. 2020 Nov 24;10(6):771-778. doi: 10.4103/jispcd.JISPCD_287_20. eCollection 2020 Nov-Dec.

Reference Type BACKGROUND
PMID: 33437712 (View on PubMed)

Sayadizadeh M, Shojaeipour R, Aminzadeh M, Horri A. Compare of the Combination of Saline and Chlorhexidine with Saline as Root Canal Irrigant in Pulpectomy of Primary Molars in 6-9 Years Old Children, A Double Blind Clinical Trial. J Dent Mater Tech 2019; 8(4): 174-181.

Reference Type BACKGROUND

Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18.

Reference Type BACKGROUND
PMID: 36808559 (View on PubMed)

Other Identifiers

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CU 30/12/2025

Identifier Type: -

Identifier Source: org_study_id

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