Plaque-Induced Gingivitis
Conditions
Keywords
Gingivitis, Thymus vulgaris, Chlorhexidine, Plaque index
Brief 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.
Detailed description
For the clinical part of the study, participants from the clinics of the Periodontics Department, College of Dentistry/University of Sulaimani will be recruited on Sunday to Wednesday from 9:00AM to 12:00AM. At the first visit, a case sheet including the participant's name, age, sex, and medical and dental history will be documented. Unstimulated saliva will be collected for the assessment of (IL-1β and MMP-8) levels. In addition, the clinical parameters (Plaque index (PLI), bleeding on probing (BOP), and gingival index (GI)) will be assessed. Furthermore, each participant will receive one of 3 different mouthwashes, which include a 0.12% CHX mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) as a positive control, distilled water combined with food additives as a negative control/placebo. The last group, TV mouthwash, will be used as a test intervention. 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, and will be instructed to refrain from eating and drinking 30 minutes after mouthwash use. To obtain proper standardization, all participants will be asked to use the same toothbrush with soft bristles (TePe® Select Soft, TePe®, Sweden), and a fluoride-containing toothpaste (Crest® Pro-Health, Crest®, USA) provided by the examiner. A detailed instruction manual will be given to each participant on how to use the mouthwash. Two weeks after the first visit, participants will be called back to evaluate the compliance with mouthwash usage and assess any potential side effects of the mouthwashes (CHX, TV, Placebo). In addition, the clinical parameters (PLI, BOP, and GI) will be re-assessed, and the saliva sample will be retaken. One month after the first visit, the clinical parameters will be reassessed, and another saliva sample will be collected for immunological and biochemical assessment. Finally, participants will be asked to complete a Visual Analogue Scale (VAS) questionnaire in order to obtain feedback for their experience with the assigned mouthwash To ensure the blindness of the study, all the mouthwashes will be dispensed in identical, opaque containers, each of which will be labelled with a random letter (A, B, or C) assigned by a third party not involved in the clinical trial. This strategy will maintain a double-blind design, where both the examiner and participants remain unaware of the intervention given throughout the study. Finally, group codes will be revealed only after the completion of the trial, during the data analysis step.
Interventions
BIOLOGICALThymus 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.
BIOLOGICALChlorhexidine 0,12%
0.12% Chlorhexidine mouthwash (Lacer Perioxidin, Lacer®, Barcelona, Spain) will be used as an active comparator to the test mouthwash.
BIOLOGICALPlacebo 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
Sponsors
University of Sulaimani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This study is a randomized, double-blind, parallel, 3-arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing | Baseline, 14 days, and 30 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Baseline, 14 days, and 30 days | Modified Quigley-Hein Plaque Index (MQHI) will be utilized to check for the amount of accumulated dental biofilm on all the surfaces of all teeth except the third molars. Six surfaces per tooth will be examined (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual). The presence of the biofilm will be visualized by using a disclosing agent (GC Tri Plaque ID Gel, GC, Japan), which will stain the teeth and allow for the identification of the available dental biofilm. the stained dental plaque will be scored on a 0-5 scale based on the MQHI, which will indicate the amount of accumulated plaque. |
| Gingival Index | Basline, 14 days, and 30 days. | Gingival index will be recorded on the mesial, distal, buccal, and lingual surfaces of all teeth except the third molars. Each surface will be carefully dried and examined under adequate illumination, and a UNC-15 periodontal probe will be used to assess the presence of bleeding following gentle probing at the gingival margin. Each surface will then be assigned a score ranging from 0 to 3. |
| Interleukin-1β (IL-1β) and Matrix Metalloproteinase-8 (MMP-8) levels | Baseline, 14 days, and 30 days. | These salivary biomarkers will be obtained by collecting saliva from participants, and assess the level of these biomarkers before and after intervention. |
Countries
Iraq
Contacts
CONTACTOmer Abdalla Yousif, Bachelor of Dental Science
CONTACTAram Mohammed Sha, PhD in Periodontics
Outcome results
None listed