Necrotic Primary TeethNCT06759766
Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant
A study testing Garlic-Lemon Extract irrigant and physiological saline in people with Necrotic Primary Teeth, run by Cairo University.
Trial summary
To evaluate the antimicrobial potency of Garlic Lemon extract irrigant versus physiological saline irrigant following partial pulpectomy in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Primary Teeth
- What is being tested?
- Garlic-Lemon Extract irrigant and physiological saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Presence of advanced physiologic or pathologic root resorption in X-ray.
- Uncooperative children.
- Teeth with unrestorable crowns.
- Teeth with abnormal anatomy and calcified canals.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
To evaluate the antimicrobial potency of Garlic Lemon extract irrigant versus physiological saline irrigant following partial pulpectomy in primary molars.
Read the 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.
- Conditions
- Necrotic Primary Teeth
- Being tested
- Garlic-Lemon Extract irrigant, physiological saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic-Lemon Extract irrigantCombination 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 salineOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count
colony forming unit (CFU) quantitative measure
Measured: pre and after irrigation within the same visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Necrotic Primary TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial, parallel group, allocation ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Yasser Yousef Mohamed, Cairo University
- Investigators
- Rasha M Hatem, Associate Professor, Study director, Pediatric Department, Faculty of Dentistry, Cairo University.Samaa S Hanafy, Lecturer, Study director, Pediatric Department, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759766
- Sponsor's protocol ID
- CU 30/12/2025
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31452953Salem, 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.
Shalan, H. M. (2023). Evaluation of Antimicrobial Efficiency of Herbal Irrigants of Pulpectomized Primary Teeth. Mansoura Journal of Dentistry, 10(2), 97-101.
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.
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.
PubMed 33437712Sayadizadeh 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.
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.
PubMed 36808559
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06759766
- Acronym / sponsor ID
- CU 30/12/2025
- Conditions
- Necrotic Primary Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial, parallel group, allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Garlic-Lemon Extract irrigant | Active comparator | Combination Product: Garlic-Lemon Extract irrigantgarlic (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 | Active comparator | Other: physiological salineNormal 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). |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence of advanced physiologic or pathologic root resorption in X-ray.
- Uncooperative children.
- Teeth with unrestorable crowns.
- Teeth with abnormal anatomy and calcified canals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic-Lemon Extract irrigantgarlic (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 salineNormal 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 irrigant |
Primary outcome
bacterial count
Time frame: pre and after irrigation within the same visit
colony forming unit (CFU) quantitative measure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 31452953Elheeny 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.
- BackgroundSalem, 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.
- BackgroundShalan, H. M. (2023). Evaluation of Antimicrobial Efficiency of Herbal Irrigants of Pulpectomized Primary Teeth. Mansoura Journal of Dentistry, 10(2), 97-101.
- BackgroundSiddique, 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: PubMed 33437712Siddique 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.
- BackgroundSayadizadeh 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: PubMed 36808559Susila 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasha M Hatem, Associate Professor study director
Pediatric Department, Faculty of Dentistry, Cairo University.
Samaa S Hanafy, Lecturer study director
Pediatric Department, Faculty of Dentistry, Cairo University.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic-Lemon Extract irrigant and physiological saline in people with Necrotic Primary Teeth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Y Yousef, masters researcher (00201066085773, nourhan-yasser@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial count (time frame: pre and after irrigation within the same visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759766, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.