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NCT07905456
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Conditions: Plaque-Induced Gingivitis
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: University of Sulaimani
Location: College of Dentistry, University of Sulaimani Sulaymaniyah
Summary
The goal of this clinical trial is to learn whether a mouthwash made from thyme (Thymus vulgaris in its scientific name) helps improve gum health in people with plaque-induced gingivitis. The mouthwash will be compared with Chlorhexidine mouthwash and a placebo (a mouthwash that does not contain the active ingredient being tested).
The main questions this study aims to answer are:
* Does Thymus vulgaris mouthwash improve gum health and lower plaque buildup and gum bleeding?
* Does it change the levels of substances in saliva linked to 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: Thymus vulgaris mouthwash, 0.12% Chlorhexidine mouthwash, or placebo. They will:
* Rinse with 10 mL of their assigned mouthwash twice daily for one minute each time.
* Have their gum health checked at the start of the study, after two weeks, and after one month.
* Provide saliva samples at each visit for testing.
* Report any side effects and share their experience with the mouthwash.
To help ensure a fair comparison, the mouthwashes will be provided in identical containers with coded labels. Neither participants nor the examiner will know which mouthwash each participant receives until the study is completed and the results are analyzed.
Eligibility Criteria
Inclusion Criteria:
The study's inclusion criteria include individuals who are:
1. 18 - 45 years of age.
2. Diagnosed with biofilm-induced generalized gingivitis (\>30% BOP sites, no loss of periodontal attachment (25)).
3. Possessing more than 20 natural teeth.
4. Non-smokers and in good systemic health (ASA I according to the American Society of Anesthesiologists classification (26)).
Exclusion Criteria:
The study's exclusion criteria consist of individuals who:
1. Have active dental caries requiring immediate treatment.
2. Absence of true periodontal pocket.
3. Have ongoing orthodontic treatment.
4. Are pregnant or intend to become pregnant.
5. Are lactating mothers.
6. Received periodontal treatment and/or antibiotics within the past 3 months.
7. Are allergic to herbal products or mouthwashes.
8. Have any known chronic systemic disease.
Source: ClinicalTrials.gov (NCT07905456). StuddyBuddy aggregates publicly available trial information.