Evaluation of the efficacy of irrigation with pomegranate peel extract and apple cider vinegar in disinfecting the necrotic root canals of primary teeth
| ISRCTN | ISRCTN79064400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79064400 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2653 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 31/05/2023
- Registration date
- 02/06/2023
- Last edited
- 08/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to improve the effectiveness of root canal treatment in children's baby teeth by finding a safer and more pleasant alternative to sodium hypochlorite for treatment of a necrotic tooth.
A necrotic tooth refers to a tooth that has undergone tissue death or decay. It occurs when the dental pulp, which contains nerves and blood vessels, becomes infected or damaged to the point where it can no longer recover.
We will explore a new solution derived from pomegranate peel, which will be carefully prepared using a unique formula. Detailed information about this formula will be provided in published research. By utilizing this new solution, we hope to achieve better disinfection results and increase the success rate of endodontic treatment without the concerns of sodium hypochlorite's toxicity or unpleasant taste when it comes into contact with the oral cavity.
Who can participate?
Children aged 3 to 9 years old with a necrotic tooth.
What does the study involve?
In this study, we will irrigate the root canals of primary teeth with pomegranate peel extract in one group and apple cider vinegar in another group. We will compare the results of these two groups to a control group that uses sodium hypochlorite. To measure the effectiveness of each solution, we will count the number of colony-forming units (CFUs) present in the samples taken from the canals before and after irrigation with each solution. This will help us assess the disinfecting properties of pomegranate peel extract and apple cider vinegar compared to the standard sodium hypochlorite.
What are the possible benefits and risks of participating?
The potential benefits of participating in the study include the treatment of necrotic teeth with copious irrigation and disinfection, which will save the tooth from extraction. However, there is also a risk of treatment failure and the flare-up of the condition.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2023 to March 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Anas Mando, dent.anasmando@gmail.com
Contact information
Principal investigator
Damascus University
Mezzeh highway
Damascus
-
Syria
 ORCID ID |
0009-0002-4586-9132 |
|---|---|
| Phone | +963 994374279 |
| anas.mando@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional double-blinded randomized controlled comparative clinical study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | In pediatric patients with necrotic primary teeth, what is the effect of irrigation with pomegranate peel extract compared to irrigation with apple cider vinegar on disinfecting the root canals |
| Study objectives | 1. There are no significant differences between the pomegranate peel extract group and the control group in the ability to reduce the bacterial count in the canals of necrotic temporary teeth 2. There are no significant differences between the apple cider vinegar group and the control group in the ability to reduce the bacterial count in the canals of necrotic temporary teeth |
| Ethics approval(s) | Approved 13/03/2023, Directorate of Scientific Research and higher Studies (Damascus University, Damascus, Damascus Governorate, 22743, Syrian Arab Republic; +9630113392348; ap.srd@damascusuniversity.edu.sy), ref: none available |
| Health condition(s) or problem(s) studied | Disinfecting the necrotic root canals of primary teeth |
| Intervention | A randomized double-blinded, controlled, comparative clinical study comparing the efficacy of pomegranate peel extract soaked in apple cider vinegar with sodium hypochlorite liquid and with apple cider vinegar in reducing bacterial counts in the canals of anterior primary teeth. Sample description The sample size was calculated using the G-Power program (3.1.9.4) at a confidence level of 95% and a level of significance of 0.05, and based on similar previous studies, the sample will consist of 45 necrotic anterior primary teeth (incisors, laterals and canines), and the sample will be randomly distributed into three groups (n=15) using https://www.randomizer.org/ The study will be conducted on children aged from 3-9 years, and each group consisting of 15 ages will be divided as follows: 1. The first group (n = 15): irrigation of the canals with pomegranate peel extract soaked with apple cider vinegar. 2. The second group (n = 15): irrigation of the canals with apple cider vinegar. 3. The third group (control) (n = 15): irrigated the canals with 3% sodium hypochlorite. Randomization is carried out using https://www.randomizer.org. Participants are followed up at 1 week. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Disinfection of the root canals is measured by counting colony-forming units (CFUs) from the cultivated samples taken from the canals before and after irrigation with each solution |
| Key secondary outcome measure(s) |
Pain on biting measured using clinical examination at 1 week postoperatively |
| Completion date | 30/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 3 Years |
| Upper age limit | 9 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Children 3-9 years old. 2. Children who have not taken antibiotics during the past 2 months. 3. The teeth (primary incisors and canines show no signs of internal radical resorption. 4. Signs of a clinically necrotic tooth with secretion of pus or fistula. 5. Radiographical transparency around the root with resorption of less than one-third of the root. |
| Key exclusion criteria | 1. Children who have taken antibiotics within the past two months. 2. The teeth of children with systemic diseases, in which any infection may affect the general health of the child. 3. Insufficient bony support or less than half of the root length remaining |
| Date of first enrolment | 18/06/2023 |
| Date of final enrolment | 15/09/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Department of pediatric dentistry
Damascus
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Dr Anas Mando, Dent.anasmando@gmail.com, and will be published as a supplement to the result publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/02/2025 | 08/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/07/2025: Publication reference and total final enrolment added.
02/06/2023: Trial's existence confirmed by Damascus University.
