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NOT YET RECRUITING
NCT07905456
PHASE2

Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis

Sponsor: University of Sulaimani

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine whether a mouthwash made from thyme (Thymus vulgaris) helps improve gum health in people with plaque-induced gingivitis. The mouthwash will be compared with chlorhexidine mouthwash and a placebo (a mouthwash without the active ingredient being tested). The main questions this study aims to answer are: Does Thymus vulgaris mouthwash improve gum health and reduce plaque accumulation and gingival bleeding? Does it change salivary levels of substances associated with gum inflammation and tissue damage? What side effects do participants experience, and how do they rate their experience with the mouthwash? Participants will be randomly assigned to one of three groups: 0.2% Thymus vulgaris mouthwash, 0.12% chlorhexidine mouthwash, or placebo. They will: Rinse with 10 mL of their assigned mouthwash twice daily for 1 minute per use. Have their gum health assessed at the beginning of the study, after 2 weeks, and after 1 month. Provide saliva samples at each visit for laboratory testing. Report any side effects and share their experience with the assigned mouthwash. To help ensure a fair comparison, the mouthwashes will be provided in identical containers with coded labels. Neither the participants nor the examiner will know which mouthwash each participant receives until the study is completed and the group codes are revealed according to the study's blinding procedures.

Official title: Clinical and Immunological Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis: A Randomized Double-Blind Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-12-01

Completion Date

2027-05-01

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

0.2% Thymus vulgaris mouthwash

A mouthwash is made using 0.2% Thymus vulgaris essential oil by a medical professional to be used in the management of biofilm-induced gingivitis.

BIOLOGICAL

Chlorhexidine 0,12%

0.12% Chlorhexidine mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) will be used as an active comparator to the test mouthwash.

BIOLOGICAL

Placebo mouthwash

A placebo mouthwash will be used as a negative control using the same materials used to make the test mouthwash except the Thymus vulgaris essential oil

Locations (1)

College of Dentistry, University of Sulaimani

Sulaymaniyah, Iraq