Evaluation of chamomile, sage, and ginger mouthwashes in reducing plaque and gum inflammation
| ISRCTN | ISRCTN10078236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10078236 |
| Sponsor | Universitatea de Vest "Vasile Goldis" din Arad |
| Funder | Universitatea de Vest "Vasile Goldis" din Arad |
- Submission date
- 05/03/2026
- Registration date
- 06/03/2026
- Last edited
- 06/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ioana Lile
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
B-dul Revolutiei, Nr.94-96
Arad
310009
Romania
| 0009-0003-6347-3497 | |
| Phone | +40 745305221 |
| lile.ioana@uvvg.ro |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Single | |
| Purpose | Health services research | |
| Scientific title | Comparative clinical evaluation of chamomile, sage, and ginger mouthwashes in reducing plaque and gingival inflammation | |
| Study acronym | CCECSGRPGI | |
| Study objectives | This study objectives are to evaluate the short-term clinical potential of three herbal mouthwashes—Matricaria chamomilla (chamomile), Salvia officinalis (sage), and Zingiber officinale (ginger)—in reducing dental plaque and gingival inflammation in young adults. | |
| Ethics approval(s) |
Approved 13/10/2025, Research Ethics Committee of the Vasile Goldis University of Arad (bd. Revolutiei nr. 94, Arad, 310009, Romania; +40 (0)257 280 260; eticacercetarii@uvvg.ro), ref: 27 | |
| Health condition(s) or problem(s) studied | Prevention of dental plaque accumulation and prevention of gingival inflammation in young adults | |
| Intervention | A randomised controlled clinical trial conducted on 175 systemically healthy participants, allocated equally into five groups (three herbal groups, placebo, and chlorhexidine). Each herbal group used a 2% aqueous infusion three times daily for twelve weeks. Clinical assessments were performed at baseline (T0), weeks 1–4 (T1), 5–8 (T2), and 9–12 (T3), using the Silness–Löe Plaque Index and the modified Löe–Silness Gingival Index. Participants were randomly allocated to one of five study groups using a computer-generated randomisation sequence created prior to participant recruitment by an independent investigator who was not involved in enrolment, clinical examination, or data analysis. Allocation concealment was ensured by sequentially numbered, opaque, sealed envelopes containing the group assignments. The envelope was opened only after the participant was included and the baseline examination was completed. Both participants and clinical examiners were blinded to group allocation, and all mouthwash formulations were dispensed in identical opaque containers. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 05/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 175 |
| Total final enrolment | 175 |
| Key inclusion criteria | 1. Age between 20 and 45 years 2. At least 20 natural teeth and no extensive prosthetic rehabilitation 3. No orthodontic or periodontal treatment in the past 6 months 4. Willingness to use only the assigned mouthwash and follow study instructions 5. Provided written informed consent |
| Key exclusion criteria | 1. Known allergy or hypersensitivity to chamomile, sage, or ginger 2. Use of antibiotics, anti-inflammatories, or antiseptic mouthwashes within the last 4 weeks 3. Pregnant or lactating women 4. Current orthodontic appliances or extensive prosthetic restorations 5. Active caries or acute oral infections at baseline |
| Date of first enrolment | 13/10/2025 |
| Date of final enrolment | 23/10/2025 |
Locations
Countries of recruitment
- Romania
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Informed consent form | 06/03/2026 | No | No |
Additional files
- 49144 Informed consent form.pdf
- Informed consent form
Editorial Notes
06/03/2026: Trial's existence confirmed by the Institutional Ethics Committee of “Vasile Goldiș” Western University of Arad.