Clinical trial NCT06759766: Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant
Official title: Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant Following Partial Pulpectomy in Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Necrotic Primary Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial, parallel group, allocation ratio 1:1
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: bacterial count
timeFrame: pre and after irrigation within the same visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Department, Faculty of Dentistry, Cairo University.
name: Rasha M Hatem, Associate Professor
role: STUDY_DIRECTOR
affiliation: Pediatric Department, Faculty of Dentistry, Cairo University.
name: Samaa S Hanafy, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Shalan, H. M. (2023). Evaluation of Antimicrobial Efficiency of Herbal Irrigants of Pulpectomized Primary Teeth. Mansoura Journal of Dentistry, 10(2), 97-101.
citation: 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.
citation: 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.
citation: 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.
citation: 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.