Effect of natural compounds on bacterial plaque
| ISRCTN | ISRCTN16734449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16734449 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Vasile Goldis Western University of Arad |
| Funder | Investigator initiated and funded |
- Submission date
- 25/03/2025
- Registration date
- 26/03/2025
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental plaque is a sticky layer of bacteria that builds up on teeth and can lead to tooth decay (cavities) and gum disease if it isn’t removed regularly. While chemical mouthwashes like chlorhexidine are effective at reducing plaque, they can cause side effects such as staining of the teeth or a change in taste. Because of this, there is growing interest in safer, natural alternatives.
Two natural substances - propolis (a resin-like product made by bees) and green tea extract - have been shown to have antibacterial effects and have traditionally been used to help with oral health. Some early research suggests they might help reduce dental plaque, but more studies are needed to confirm how well they work compared to standard treatments.
This study was carried out to find out whether mouthrinses made with propolis or green tea could reduce dental plaque comparable to chlorhexidine. The researchers also wanted to see if these natural rinses were safe to use and whether people would use them regularly.
Who can participate?
Patients aged 18 years and over who are suffering from gingivitis
What does the study involve?
Participants will be randomly allocated to receive professional mechanical plaque removal accompanied by either propolis mouthwash, green tea mouthwash, 0.2% chlorhexidine mouthwash (positive control), or placebo rinse. Follow-up will be at 7, 14 and 28 days.
What are the possible benefits and risks of participating?
Participants may benefit from improved gum health and reduced inflammation. No risk is incurred by the use of the antimicrobial product.
Where is the study run from?
Department of Dental Medicine of the Vasile Goldiș Western University of Arad (Romania)
When is the study starting and how long is it expected to run for?
October 2022 to September 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Lile Ioana, lile.ioana@uvvg.ro
Contact information
Public, Scientific, Principal investigator
Arad str Liviu Rebreanu nr.86
Arad
310130
Romania
| lile.ioana@uvvg.ro |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-blind randomized placebo-controlled clinical trial with a parallel-group design and a 4-week duration |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 47073_PIS.pdf |
| Scientific title | Symbiosis in oral health: the role of natural compounds in dental plaque management |
| Study acronym | OH-GI-NAT-COMP |
| Study objectives | The null hypothesis (H0) was that no statistically significant differences are observed with respect to the clinical parameters pocket probing depth (PPD), bleeding on probing (BoP), plaque index (PI) and full mouth bleeding score (FMBS) between the treatment modalities. |
| Ethics approval(s) |
Approved 10/01/2025, Research Ethics Committee of the Vasile Goldis University of Arad (bd. Revolutiei nr. 94, Arad, 310130, Romania; +40 (0)257 280 260; eticacercetarii@uvvg.ro), ref: 01/10/01/2025 |
| Health condition(s) or problem(s) studied | Gingivitis |
| Intervention | Prior to treatment, full-mouth supragingival scaling was performed in all subjects. Each patient was assigned to one of the four treatment groups according to computer-generated randomization. Participants will be randomly allocated to receive professional mechanical plaque removal (PMPR) accompanied by either propolis mouthwash, green tea mouthwash, 0.2% chlorhexidine mouthwash (positive control), or placebo rinse. Follow-up will be at 7, 14 and 28 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Plaque measured using plaque index (PI) at baseline and 4 weeks |
| Key secondary outcome measure(s) |
1. Gingival inflammation measured using the Gingival Index (GI) at baseline and 4 weeks |
| Completion date | 03/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Age 18–50 years, systemically healthy 2. Minimum of 20 natural teeth present 3. Moderate plaque accumulation (baseline Plaque Index score between 1.5-3.0) 4. No professional dental cleaning within the past 3 months |
| Key exclusion criteria | 1. Any systemic condition requiring antibiotic prophylaxis 2. Use of antibiotics or antiseptic mouthrinses in the last 4 weeks 3. Ongoing dental treatment or recent periodontal therapy 4. Known allergy to any product ingredients (propolis, tea, or chlorhexidine) 5. Pregnant or lactating women 6. Failure to sign written informed consent |
| Date of first enrolment | 10/01/2025 |
| Date of final enrolment | 10/04/2025 |
Locations
Countries of recruitment
- Romania
Study participating centre
Arad
310045
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analyzed during the study will be stored in a non-publically available repository: the archives of the Department of Dental Medicine of the Vasile Goldiș Western University of Arad. The data will become available 5 years after the end of the study, indefinitely. Data anonymisation: numbers were attributed to patients’ names. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/03/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47073_PIS.pdf
- Participant information sheet
Editorial Notes
25/03/2025: Study's existence confirmed by the Research Ethics Committee of the Vasile Goldis University of Arad.
