Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis

March 31, 2025 updated by: Candan Pelin, Altinbas University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakirkoy
      • İstanbul, Bakirkoy, Turkey, 34149
        • Altinbas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Using of any antioxidant or antimicrobial agent in the last 6 months

    •. Smoking

  • Pregnancy
  • Alcoholism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tea Tree Oil Mouthwash Group
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.
Drug: Tea tree oil
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.
Active Comparator: non-alcohol EO mouthwash group
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)
Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT
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.
Active Comparator: thyme-containing hydrosol group
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).
Drug: Thyme oil hydrosol
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.
Placebo Comparator: Control group
placebo group, patients who were administered placebo mouthwash (15 mL of placebo mouthwash for 1 min.) (n=13)
Drug: Placebo
Placebo mouthwash had been used in 13 patients for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
PPD is an important parameter in the evaluation of the treatment of periodontal diseases.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altinbas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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