Periodontal DiseasesPhase 4NCT06904742
Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis
A Phase 4 study testing Tea tree oil, Thyme oil hydrosol and LISTERINE ZERO Alcohol Mouthwash COOL MINT in people with Periodontal Diseases, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial summary
Plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. It is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Tea tree oil, Thyme oil hydrosol and LISTERINE ZERO Alcohol Mouthwash COOL MINT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2025to 15 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- According to EFP in 2017, gingivitis patients with a PPD ≤3 mm, BOP in the whole mouth ≥ % 10 and no radiological bone loss
- Having ≥ 20 teeth
- Male or female ≥ 18 years old
- Systemically healthy patients
Who cannot join
- Using of any antioxidant or antimicrobial agent in the last 6 months
- •. Smoking
- Pregnancy
- Alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. It is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. This randomize controlled clinical trial (RCT) aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non-surgical periodontal therapy (NSPT) in patients with gingivitis. A total of 52 patients diagnosed with gingivitis were incorporated into the RCT and categorized into four groups as follows: Tea tree oil (Tebodont®), thyme hydrosol (Arifoglu®), essential oil (Listerine®), and placebo. The patients were advised to wash with15 ml of prescribed mouthwash twice a day for a period of 3rd months after NSPT. Clinical periodontal measurements; including plaque index (PI), gingival index (GI) and probing pocket depth (PPD) and microbiological sampling, were performed before enrollment and in 3rd months. Plaque samples were examined by quantitative polymerase chain reaction(qPCR).
Read the detailed description
This randomize controlled clinical trial aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non- surgical periodontal therapy in patients with gingivitis.
- Conditions
- Periodontal Diseases
- Being tested
- Tea tree oil, Thyme oil hydrosol, LISTERINE ZERO Alcohol Mouthwash COOL MINT, Placebo
- Keywords
- gingivitis, essential oil, tea tree oil, thyme, qPCR
- Medical subject headings
- Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea tree oilDrug
Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily . Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s. In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.
Thyme oil hydrosolDrug
Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily (Santi et al., 2019). Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s (Santi et al., 2019). In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.
LISTERINE ZERO Alcohol Mouthwash COOL MINTDrug
Our study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily. Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s . In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses.
PlaceboDrug
Placebo mouthwash had been used in 13 patients for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Tea Tree Oil Mouthwash Group | Active comparator | Patients were randomized to receive the respective mouthwashes. Participants were instructed to use 15 mL of mouthwash twice-daily for one minute per application and to avoid from rinsing or consuming food for 30 minutes post-application. Receives: Drug: Tea tree oil |
| non-alcohol EO mouthwash group | Active comparator | Group II; non-alcohol EO mouthwash group, patients who were administered non-alcohol essential oil mouthwash (15 mL of (Listerine Total Care Zero Mouthwash, Listerine ® for 1 min) (n=13) Receives: Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT |
| thyme-containing hydrosol group | Active comparator | Group III; thyme-containing hydrosol group, of patients who were administered thyme-containing Mouthwash (15 mL of thyme hydrosol, Arifoğlu ®for 1 min) (n = 13). Receives: Drug: Thyme oil hydrosol |
| Control group | Placebo comparator | placebo group, patients who were administered placebo mouthwash (15 mL of placebo mouthwash for 1 min.) (n=13) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in PI
PI is the amount of microbial dental plaque assesed on 6 sites of per tooth. In addition to mechanical plaque control, plaque index was our primary evaluation of the mechanism of action of mouthwashes in our study.
Measured: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Reduction in GI
GI introduce system for the assessment of gingival condition. For the evaluation of the index, 6 points (mesiobuccal, midpoint, distobuccal; mesiopalatinal, midpoint, distopalatinal) are examined according to the presence of bleeding that occurs after the examination with the probe and index values between 0-3 are given.
Measured: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Reduction in Bleeding on Probing
Bleeding on probing is one of the important parameters in the diagnosis of gingivitis, reduction in bleeding on probing is the primary outcomed.
Measured: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Secondary outcomes (1)
Reduction in PPD
PPD is an important parameter in the evaluation of the treatment of periodontal diseases.
Measured: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start28 Feb 2025
- Primary completion17 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candan Pelin, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904742
- Sponsor's protocol ID
- 2023/213
- Status last verified
- Mar 2025
- First submitted
- 27 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis
- ClinicalTrials.gov ID
- NCT06904742
- Acronym / sponsor ID
- 2023/213
- Conditions
- Periodontal Diseases
- Keywords
- gingivitis, essential oil, tea tree oil, thyme, qPCR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 1 Apr 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.
Plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. It is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. This randomize controlled clinical trial (RCT) aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non-surgical periodontal therapy (NSPT) in patients with gingivitis. A total of 52 patients diagnosed with gingivitis were incorporated into the RCT and categorized into four groups as follows: Tea tree oil (Tebodont®), thyme hydrosol (Arifoglu®), essential oil (Listerine®), and placebo. The patients were advised to wash with15 ml of prescribed mouthwash twice a day for a period of 3rd months after NSPT. Clinical periodontal measurements; including plaque index (PI), gingival index (GI) and probing pocket depth (PPD) and microbiological sampling, were performed before enrollment and in 3rd months. Plaque samples were examined by quantitative polymerase chain reaction(qPCR).
Detailed description
This randomize controlled clinical trial aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non- surgical periodontal therapy in patients with gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tea Tree Oil Mouthwash Group | Active comparator | Drug: Tea tree oilPatients were randomized to receive the respective mouthwashes. Participants were instructed to use 15 mL of mouthwash twice-daily for one minute per application and to avoid from rinsing or consuming food for 30 minutes post-application. |
| non-alcohol EO mouthwash group | Active comparator | Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINTGroup II; non-alcohol EO mouthwash group, patients who were administered non-alcohol essential oil mouthwash (15 mL of (Listerine Total Care Zero Mouthwash, Listerine ® for 1 min) (n=13) |
| thyme-containing hydrosol group | Active comparator | Drug: Thyme oil hydrosolGroup III; thyme-containing hydrosol group, of patients who were administered thyme-containing Mouthwash (15 mL of thyme hydrosol, Arifoğlu ®for 1 min) (n = 13). |
| Control group | Placebo comparator | Drug: Placeboplacebo group, patients who were administered placebo mouthwash (15 mL of placebo mouthwash for 1 min.) (n=13) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- According to EFP in 2017, gingivitis patients with a PPD ≤3 mm, BOP in the whole mouth ≥ % 10 and no radiological bone loss
- Having ≥ 20 teeth
- Male or female ≥ 18 years old
- Systemically healthy patients
Key exclusion criteria (4 listed)
- Using of any antioxidant or antimicrobial agent in the last 6 months
- •. Smoking
- Pregnancy
- Alcoholism
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 |
|---|---|---|
| Tea tree oilOur study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily . Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s. In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses. | Drug | Tea Tree Oil Mouthwash Group |
| Thyme oil hydrosolOur study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily (Santi et al., 2019). Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s (Santi et al., 2019). In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses. | Drug | thyme-containing hydrosol group |
| LISTERINE ZERO Alcohol Mouthwash COOL MINTOur study's findings might have a important impact on the field of periodontology, providing valuable insights into the potential of herbal mouthwashes as an adjunct to NSPT in gingivitis treatment. A literature review reveals that regarding the mouthwash protocols, most studies mentioned use twice daily. Most studies used 10-15 ml as a dose, and rinsing time ranged from 30-90 s . In this study, similar to the literature, patients were prescribed to rinse twice daily, 15 ml for 30 s. The operator explained information about oral hygiene practices at baseline. With this approach, adequate mechanical cleaning action was obtained, and participants became more aware of importance of oral hygiene. Low scores of PI and GI in placebo group at 3rd month can be attributed to this interaction and can mask the maximum effects of herbal mouth rinses. | Drug | non-alcohol EO mouthwash group |
| PlaceboPlacebo mouthwash had been used in 13 patients for 3 months | Drug | Control group |
Primary outcome
Reduction in PI
Time frame: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
PI is the amount of microbial dental plaque assesed on 6 sites of per tooth. In addition to mechanical plaque control, plaque index was our primary evaluation of the mechanism of action of mouthwashes in our study.
Reduction in GI
Time frame: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
GI introduce system for the assessment of gingival condition. For the evaluation of the index, 6 points (mesiobuccal, midpoint, distobuccal; mesiopalatinal, midpoint, distopalatinal) are examined according to the presence of bleeding that occurs after the examination with the probe and index values between 0-3 are given.
Reduction in Bleeding on Probing
Time frame: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Bleeding on probing is one of the important parameters in the diagnosis of gingivitis, reduction in bleeding on probing is the primary outcomed.
1 secondary outcome
Reduction in PPD
Time frame: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tea tree oil, Thyme oil hydrosol and LISTERINE ZERO Alcohol Mouthwash COOL MINT in people with Periodontal Diseases, run by Altinbas University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PI (time frame: Each patient in the trial was followed up for 3rd month. During the follow up, at 30 days the patients were called to the clinic.The data were recorded at baseline and 3rd month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.