Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Clinical and Immunological Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis: A Randomized Double-Blind Clinical Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2026
Actual (reported)October 29, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Bleeding on Probing
This index will be assessed by gently inserting a periodontal probe into the gingival sulcus or pocket parallel to the long axis of the tooth and using a light force of 20-25 grams. Scores will be assigned based on the absence or presence of bleeding after 15-30 seconds of probing at a site (0= no bleeding, 1= bleeding)
Baseline, 14 days, and 30 days
Plaque Index
Baseline, 14 days, and 30 days
Gingival Index
Basline, 14 days, and 30 days.
Interleukin-1β (IL-1β) and Matrix Metalloproteinase-8 (MMP-8) levels
Baseline, 14 days, and 30 days.
The participants will be asked to rinse with 10 mL of the assigned mouthwash twice a day for 1 minute for each use, 30 minutes after toothbrushing to evaluate its efficacy in the management of biofilm-induced gingivitis by assessing its impact on plaque index (PLI), bleeding on probing (BOP), gingival index (GI), salivary level of pro-inflammatory mediators (IL-1β and MMP-8) in comparison to a placebo and Chlorhexidine mouthwash
The participants will be asked to rinse with 10 mL of the assigned mouthwash twice a day for 1 minute for each use, 30 minutes after toothbrushing. The aim of this group is to compare its results with the test group and to show the efficacy of the novel 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.
0.12% Chlorhexidine mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) will be used as an active comparator to the test mouthwash.
College of Dentistry, University of Sulaimani
Sulaymaniyah, 46001, Iraq
Micucci M, Protti M, Aldini R, Frosini M, Corazza I, Marzetti C, Mattioli LB, Tocci G, Chiarini A, Mercolini L, Budriesi R. Thymus vulgaris L. Essential Oil Solid Formulation: Chemical Profile and Spasmolytic and Antimicrobial Effects. Biomolecules. 2020 Jun 4;10(6):860. doi: 10.3390/biom10060860.
Waheed M, Hussain MB, Saeed F, Afzaal M, Ahmed A, Irfan R, Akram N, Ahmed F, Hailu GG. Phytochemical Profiling and Therapeutic Potential of Thyme (Thymus spp.): A Medicinal Herb. Food Sci Nutr. 2024 Nov 1;12(12):9893-9912. doi: 10.1002/fsn3.4563. eCollection 2024 Dec.
First Submitted
October 22, 2026
First Posted
October 29, 2026
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The participants will be asked to rinse with 10 mL of the assigned mouthwash twice a day for 1 minute for each use, 30 minutes after toothbrushing. The aim of this group is to compare its results with the test group and to show the efficacy of the novel Thymus vulgaris 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
Contact the study team to confirm eligibility.
Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S46-S73. doi: 10.1002/JPER.17-0576.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the results reported in the published article will be made available, including clinical measurements (Plaque Index, Bleeding on Probing, and Gingival Index), salivary biomarker measurements (interleukin-1 beta and matrix metalloproteinase-8), treatment group assignments, and assessment time points. The dataset will exclude direct personal identifiers.
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Source: ClinicalTrials.gov.
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