Plaque-Induced GingivitisPhase 2NCT07905456
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
A Phase 2 study testing 0.2% Thymus vulgaris mouthwash and Chlorhexidine 0,12% in people with Plaque-Induced Gingivitis, run by University of Sulaimani at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Plaque-Induced Gingivitis
- What is being tested?
- 0.2% Thymus vulgaris mouthwash and Chlorhexidine 0,12%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2026to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Aged 18-45 years.
- Diagnosed with biofilm-induced generalized gingivitis, characterized by bleeding on probing at more than 30% of periodontal sites and no periodontitis-related clinical attachment loss
- Having more than 20 natural teeth
- Non-smokers and in good systemic health, classified as American Society of Anesthesiologists (ASA) Physical Status I.
Who cannot join
- Individuals meeting any of the following criteria will be excluded:
- Have active dental caries requiring immediate treatment.
- Have periodontitis or periodontal pocketing inconsistent with the study's gingivitis case definition.
- Are undergoing orthodontic treatment.
- Are pregnant or planning to become pregnant during the study period.
- Are breastfeeding.
Show all 9Show fewer
- 5. Have received periodontal treatment or systemic antibiotics within the previous 3 months.
- 6. Have a known allergy or hypersensitivity to herbal products or any ingredient in the study mouthwashes.
- 7. Have a known chronic systemic disease that is inconsistent with the study's eligibility requirement of ASA Physical Status I.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
College of Dentistry, University of Sulaimani
Sulaymaniyah, 46001
Omer Abdalla Yousif, Bachelor of Dental Science, +9647702221140, omer.yousif@univsul.edu.iq
Aram Mohammed Sha, PhD in Periodontics, +9647701211911, aram.hamad@univsul.edu.iq
About this study
Official title: Clinical and Immunological Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis: A Randomized Double-Blind Clinical Trial
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:
Read more
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.
Read the detailed description
For the clinical part of the study, participants will be recruited from the clinics of the Periodontics Department, College of Dentistry, University of Sulaimani, from Sunday to Wednesday, between 9:00 AM and 12:00 PM.
At the first visit, a case sheet will be completed to document each participant's name, age, sex, and medical and dental history. Unstimulated saliva will be collected to assess interleukin-1 beta (IL-1β) and matrix metalloproteinase-8 (MMP-8) concentrations. In addition, the clinical parameters, including the Plaque Index (PLI), Bleeding on Probing (BOP), and Gingival Index (GI), will be assessed.
Each participant will be randomly assigned to one of three mouthwash groups: (1) a 0.12% chlorhexidine (CHX) mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain), serving as the positive control; (2) a 0.2% Thymus vulgaris (TV) mouthwash, serving as the test intervention; or (3) a placebo mouthwash containing the same excipients as the test mouthwash but without Thymus vulgaris essential oil.
Participants will be instructed to rinse with 10 mL of their assigned mouthwash twice daily for 1 minute per use, 30 minutes after toothbrushing. They will also be instructed to refrain from eating and drinking for 30 minutes after using the mouthwash.
To standardize oral hygiene practices, all participants will be provided with the same soft-bristled toothbrush (TePe® Select Soft, TePe®, Sweden) and fluoride-containing toothpaste (Crest® Pro-Health, Crest®, USA). Each participant will receive a detailed instruction manual explaining how to use the assigned mouthwash.
Two weeks after the initial visit, participants will return for an assessment of adherence to mouthwash use and any potential side effects associated with the assigned mouthwash. The clinical parameters (PLI, BOP, and GI) will be reassessed, and another unstimulated saliva sample will be collected.
One month after the initial visit, the clinical parameters will be reassessed, and another unstimulated saliva sample will be collected for immunological and biochemical assessment. Participants will also be asked to complete a Visual Analogue Scale (VAS) questionnaire to provide feedback on their experience with the assigned mouthwash.
To maintain blinding, all mouthwashes will be dispensed in identical, opaque containers labeled with randomly assigned letters (A, B, or C) by a third party who is not involved in the clinical trial. This procedure is intended to maintain a double-blind design in which both participants and the clinical examiner remain unaware of the assigned intervention throughout the study. The group codes will be revealed only after completion of the trial, in accordance with the study's blinding and data-analysis procedures.
- Conditions
- Plaque-Induced Gingivitis
- Being tested
- 0.2% Thymus vulgaris mouthwash, Chlorhexidine 0,12%, Placebo mouthwash
- Keywords
- Gingivitis, Thymus vulgaris, Chlorhexidine, Plaque index
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2% Thymus vulgaris mouthwashBiological
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.
Chlorhexidine 0,12%Biological
0.12% Chlorhexidine mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) will be used as an active comparator to the test mouthwash.
Placebo mouthwashBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving 0.2% Thymus vulgaris mouthwash (test group) | Experimental | Participants will be instructed to rinse with 10 mL of their assigned mouthwash twice daily for 1 minute per use, 30 minutes after toothbrushing. The efficacy of the Thymus vulgaris mouthwash in managing biofilm-induced gingivitis will be evaluated by assessing changes in the Plaque Index (PLI), Bleeding on Probing (BOP), Gingival Index (GI), and salivary concentrations of the pro-inflammatory mediators interleukin-1 beta (IL-1β) and matrix metalloproteinase-8 (MMP-8), compared with the placebo and chlorhexidine mouthwash groups. Receives: Biological: 0.2% Thymus vulgaris mouthwash |
| Participants receiving Chlorhexidine mouthwash (positive control group) | Active comparator | 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. Receives: Biological: Chlorhexidine 0,12% |
| Participants receiving a placebo mouthwash (negative control group) | Placebo comparator | 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. Receives: Biological: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BoP)
Bleeding on Probing (BOP) will be assessed by gently inserting a periodontal probe into the gingival sulcus or periodontal pocket, parallel to the long axis of the tooth, using a probing force of approximately 20-25 grams. Bleeding will be assessed 15-30 seconds after probing at each site. Each site will be scored as 0 (no bleeding) or 1 (bleeding present). The possible score for each site ranges from 0 to 1, with higher scores indicating the presence of bleeding and a worse outcome. If expressed as a percentage, BOP will be calculated as the number of sites exhibiting bleeding divided by the total number of sites examined, multiplied by 100; percentages range from 0% to 100%, with higher values indicating more bleeding and a worse outcome.
Measured: Baseline, 14 days, and 30 days
Secondary outcomes (4)
Plaque Index (PI)
The Modified Quigley-Hein Plaque Index (MQHI) will be used to assess the amount of accumulated dental plaque on all tooth surfaces, excluding the third molars. Six surfaces per tooth will be examined: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual. Dental plaque will be visualized using a disclosing agent (GC Tri Plaque ID Gel, GC Corporation, Japan). Each examined surface will be scored on a scale from 0 to 5 according to the Modified Quigley-Hein Plaque Index criteria, with 0 indicating no plaque and 5 indicating extensive plaque accumulation. The participant's plaque score will be calculated as the mean score of all examined surfaces. Possible mean scores range from 0 to 5, with higher scores indicating greater plaque accumulation and a worse outcome.
Measured: Baseline, 14 days, and 30 days
Gingival Index (GI)
Gingival Index (GI) will be used to assess the severity of gingival inflammation on the mesial, distal, buccal, and lingual surfaces of all teeth, excluding the third molars. The gingiva will be examined under adequate illumination, and a UNC-15 periodontal probe will be used gently to assess gingival tissue consistency and bleeding tendency where indicated by the index criteria. Each surface will be assigned a score from 0 to 3: 0 indicates normal gingiva with no inflammation; 1 indicates mild inflammation with slight changes in color and texture but no bleeding on probing; 2 indicates moderate inflammation with redness, edema, and bleeding on probing; and 3 indicates severe inflammation with marked redness and edema, ulceration, and a tendency toward spontaneous bleeding. The participant's GI score will be calculated as the mean score of all examined surfaces. Possible mean scores range from 0 to 3, with higher scores indicating more severe gingival inflammation and a worse outcome.
Measured: Basline, 14 days, and 30 days.
Salivary Interleukin-1 Beta (IL-1β) Concentration
Salivary interleukin-1 beta (IL-1β) concentration will be quantified using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's instructions for sample preparation, assay procedures, and result calculation. Results will be expressed in picograms per milliliter (pg/mL).
Measured: Baseline, 14 days, and 30 days.
Salivary Matrix Metalloproteinase-8 (MMP-8) Concentration
Salivary matrix metalloproteinase-8 (MMP-8) concentration will be quantified using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's instructions for sample preparation, assay procedures, and result calculation. Results will be expressed in picograms per milliliter (pg/mL).
Measured: Baseline, 14 days, and 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plaque-Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, double-blind, parallel, 3-arm clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Abdalla Yousif, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905456
- Sponsor's protocol ID
- COD-EC-26-0135
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32512899Waheed 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.
PubMed 39723027Trombelli 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.
PubMed 29926936
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunological Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis: A Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07905456
- Acronym / sponsor ID
- COD-EC-26-0135
- Conditions
- Plaque-Induced Gingivitis
- Keywords
- Gingivitis, Thymus vulgaris, Chlorhexidine, Plaque index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For the clinical part of the study, participants will be recruited from the clinics of the Periodontics Department, College of Dentistry, University of Sulaimani, from Sunday to Wednesday, between 9:00 AM and 12:00 PM.
At the first visit, a case sheet will be completed to document each participant's name, age, sex, and medical and dental history. Unstimulated saliva will be collected to assess interleukin-1 beta (IL-1β) and matrix metalloproteinase-8 (MMP-8) concentrations. In addition, the clinical parameters, including the Plaque Index (PLI), Bleeding on Probing (BOP), and Gingival Index (GI), will be assessed.
Each participant will be randomly assigned to one of three mouthwash groups: (1) a 0.12% chlorhexidine (CHX) mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain), serving as the positive control; (2) a 0.2% Thymus vulgaris (TV) mouthwash, serving as the test intervention; or (3) a placebo mouthwash containing the same excipients as the test mouthwash but without Thymus vulgaris essential oil.
Participants will be instructed to rinse with 10 mL of their assigned mouthwash twice daily for 1 minute per use, 30 minutes after toothbrushing. They will also be instructed to refrain from eating and drinking for 30 minutes after using the mouthwash.
To standardize oral hygiene practices, all participants will be provided with the same soft-bristled toothbrush (TePe® Select Soft, TePe®, Sweden) and fluoride-containing toothpaste (Crest® Pro-Health, Crest®, USA). Each participant will receive a detailed instruction manual explaining how to use the assigned mouthwash.
Two weeks after the initial visit, participants will return for an assessment of adherence to mouthwash use and any potential side effects associated with the assigned mouthwash. The clinical parameters (PLI, BOP, and GI) will be reassessed, and another unstimulated saliva sample will be collected.
One month after the initial visit, the clinical parameters will be reassessed, and another unstimulated saliva sample will be collected for immunological and biochemical assessment. Participants will also be asked to complete a Visual Analogue Scale (VAS) questionnaire to provide feedback on their experience with the assigned mouthwash.
To maintain blinding, all mouthwashes will be dispensed in identical, opaque containers labeled with randomly assigned letters (A, B, or C) by a third party who is not involved in the clinical trial. This procedure is intended to maintain a double-blind design in which both participants and the clinical examiner remain unaware of the assigned intervention throughout the study. The group codes will be revealed only after completion of the trial, in accordance with the study's blinding and data-analysis procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This study is a randomized, double-blind, parallel, 3-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Participants receiving 0.2% Thymus vulgaris mouthwash (test group) | Experimental | Biological: 0.2% Thymus vulgaris mouthwashParticipants will be instructed to rinse with 10 mL of their assigned mouthwash twice daily for 1 minute per use, 30 minutes after toothbrushing. The efficacy of the Thymus vulgaris mouthwash in managing biofilm-induced gingivitis will be evaluated by assessing changes in the Plaque Index (PLI), Bleeding on Probing (BOP), Gingival Index (GI), and salivary concentrations of the pro-inflammatory mediators interleukin-1 beta (IL-1β) and matrix metalloproteinase-8 (MMP-8), compared with the placebo and chlorhexidine mouthwash groups. |
| Participants receiving Chlorhexidine mouthwash (positive control group) | Active comparator | Biological: Chlorhexidine 0,12%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. |
| Participants receiving a placebo mouthwash (negative control group) | Placebo comparator | Biological: Placebo mouthwashThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-45 years.
- Diagnosed with biofilm-induced generalized gingivitis, characterized by bleeding on probing at more than 30% of periodontal sites and no periodontitis-related clinical attachment loss
- Having more than 20 natural teeth
- Non-smokers and in good systemic health, classified as American Society of Anesthesiologists (ASA) Physical Status I.
Key exclusion criteria (9 listed)
- Have active dental caries requiring immediate treatment.
- Have periodontitis or periodontal pocketing inconsistent with the study's gingivitis case definition.
- Are undergoing orthodontic treatment.
- Are pregnant or planning to become pregnant during the study period.
- Are breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.2% Thymus vulgaris mouthwashA 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 | Participants receiving 0.2% Thymus vulgaris mouthwash (test group) |
| Chlorhexidine 0,12%0.12% Chlorhexidine mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) will be used as an active comparator to the test mouthwash. | Biological | Participants receiving Chlorhexidine mouthwash (positive control group) |
| Placebo mouthwashA 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 | Biological | Participants receiving a placebo mouthwash (negative control group) |
Primary outcome
Bleeding on Probing (BoP)
Time frame: Baseline, 14 days, and 30 days
Bleeding on Probing (BOP) will be assessed by gently inserting a periodontal probe into the gingival sulcus or periodontal pocket, parallel to the long axis of the tooth, using a probing force of approximately 20-25 grams. Bleeding will be assessed 15-30 seconds after probing at each site. Each site will be scored as 0 (no bleeding) or 1 (bleeding present). The possible score for each site ranges from 0 to 1, with higher scores indicating the presence of bleeding and a worse outcome. If expressed as a percentage, BOP will be calculated as the number of sites exhibiting bleeding divided by the total number of sites examined, multiplied by 100; percentages range from 0% to 100%, with higher values indicating more bleeding and a worse outcome.
4 secondary outcomes
Plaque Index (PI)
Time frame: Baseline, 14 days, and 30 days
Gingival Index (GI)
Time frame: Basline, 14 days, and 30 days.
Salivary Interleukin-1 Beta (IL-1β) Concentration
Time frame: Baseline, 14 days, and 30 days.
Salivary Matrix Metalloproteinase-8 (MMP-8) Concentration
Time frame: Baseline, 14 days, and 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 32512899Micucci 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.
- Background: PubMed 39723027Waheed 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.
- Background: PubMed 29926936Trombelli 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.2% Thymus vulgaris mouthwash and Chlorhexidine 0,12% in people with Plaque-Induced Gingivitis, run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omer Abdalla Yousif, Bachelor of Dental Science (+9647702221140, omer.yousif@univsul.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (BoP) (time frame: Baseline, 14 days, and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07905456, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.