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

Phase 4

Completed

• Conditions: Periodontal Diseases
• Interventions: Drug: Tea tree oil; Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT; Drug: Thyme oil hydrosol; Drug: Placebo

• Registration Number: NCT06904742
• Lead Sponsor: Altinbas University

Brief 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. 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 Timeline

• Study Start: 2024-02-12
• Primary Completion: 2024-06-17
• Study Completion: 2024-07-15
• Study First Submitted: 2025-01-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tea Tree Oil Mouthwash Group	Tea tree oil	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.
non-alcohol EO mouthwash group	LISTERINE ZERO Alcohol Mouthwash COOL MINT	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)
thyme-containing hydrosol group	Thyme oil hydrosol	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).
Control group	Placebo	placebo group, patients who were administered placebo mouthwash (15 mL of placebo mouthwash for 1 min.) (n=13)

Primary Outcome Measures

Name	Time	Method
Reduction in PI	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Reduction in PPD	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.

Trial Locations

Locations (1)

Altinbas University; 🇹🇷 İstanbul, Bakirkoy, Turkey