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

NCT06759766 | Not Yet Recruiting

• 1 other identifier: CU 30/12/2025
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Necrotic Primary Teeth

Outcome Measures

Primary Outcomes (1)

• bacterial count

  colony forming unit (CFU) quantitative measure

  pre and after irrigation within the same visit

Study Arms (2)

Garlic-Lemon Extract irrigant

ACTIVE COMPARATOR

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

physiological saline irrigant

ACTIVE COMPARATOR

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

Interventions

Garlic-Lemon Extract irrigant 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).

Garlic-Lemon Extract irrigant

physiological saline 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).

physiological saline irrigant

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• 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.

  PMID: 31452953 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  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.

  PMID: 33437712 BACKGROUND

• 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.

  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.

  PMID: 36808559 BACKGROUND

Study Officials

• 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.

  STUDY DIRECTOR

Central Study Contacts

Nourhan Y Yousef, masters researcher

CONTACT

00201066085773; nourhan-yasser@dentistry.cu.edu.eg

Rasha M Hatem, Assoc.Prof.

CONTACT

00201001670222; rasha.hatem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: A randomized controlled clinical trial, parallel group, allocation ratio 1:1

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01