- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364565
The Antiplaque and Antigingivitis Effect of Pure Green Tea Mouth Wash Compared to Placebo and Essential Oils Mouth Washes
The Antiplaque and Antigingivitis Effect of Pure Green Tea Mouth Wash Compared to Placebo and Essential Oils Mouth Washes: A Double Blinded Randomized Controlled Clinical Trial.
The goal of this clinical trial is to to evaluate the antiplaque and antigingivitis effect of pure green tea mouthwash compared to placebo and essential oils mouthwashes in healthy patients.
The main questions it aims to answer are:
- Does pure green tea mouthwash effectively reduce dental plaque?
- Does pure green tea mouthwash reduce gingival inflammation?
Researchers will compare pure green tea mouthwash to Listerine Total Care, Listerine Green Tea, and placebo to see if there is a difference in plaque accumulation and gum inflammation reduction.
Participants will be prohibited from using any sort of oral hygiene parctice for the whole study period (3 weeks). Instead, they will rinse with 10 ml of their assigned mouthwash twice daily for 30 seconds. Plaque index, gingival index, and staining index will be examined at multiple intervals and participants will rate their sense of oral freshness and good breath.
Study Overview
Status
Conditions
Detailed Description
• Study Design
This study will be a double-blinded, randomized, controlled, clinical trial with a parallel group design. Participants will be randomly allocated into four groups:
Group P: placebo (pure water with a flavored additive) solution. Group T1: pure green tea mouthwash. Group T2: Listerine Total Care mouthwash. Group T3: Listerine Green Tea mouthwash.
All participants will be instructed to rinse with 10 ml of the assigned mouthwash for 30 seconds twice daily over a three-week experimental period. The study will follow the experimental gingivitis model, during which participants will refrain from all forms of mechanical plaque control.
- Sample Size A total of 44 dental participants, aged between 18-50 years, will be recruited. Each group will consist of 11 participants, providing a power of 80% to detect a difference of 0.2 in mean plaque index values between groups, with a p-value < 0.05 and a β-error of 20%.
- Ethical Considerations All participants will be informed about the study objectives, methodology, and possible risks. Written informed consent will be obtained before participation. All procedures will follow ethical standards and the principles of the Declaration of Helsinki.
- Data Collection and Clinical Assessments Clinical examinations will be performed at baseline (T0), day 7 (T1), day 14 (T2), and day 21 (T3). The following parameters will be recorded: plaque index, gingival index, staining index, and patients reported outcome in regards to their perciption of freshness and good breath.
After the experimental period (T3), participants will receive a professional cleaning and fluoride application, and will be followed for two additional weeks to ensure the restoration of oral health.
- Randomization and Blinding Randomization will be performed using a computer-generated sequence by an independent researcher. The mouthwash samples will be provided in coded and unlabeled containers to ensure blinding of both participants and the examiner. A third party will be responsible about desposing the assigned mouth wash to the patients.
- Adverse Events Monitoring Participants will be closely monitored throughout the study for any possible adverse effects such as gingival irritation, sensitivity, or allergic reactions. Any incident will be documented and managed according to the study protocol. Any participant who experience an adverse event will be excluded from the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lana Bader, DClinDent Perio
- Phone Number: +962791200956
- Email: lmbader4@just.edu.jo
Study Contact Backup
- Name: Dana Adel Abdullah, MClinDent Perio
- Phone Number: +962796653746
- Email: lana.bader@yahoo.com
Study Locations
-
-
Irbid Governorate
-
Irbid, Irbid Governorate, Jordan, 22110
- Recruiting
- Jordan University of Science and Technology, Faculty of Dentistry
-
Contact:
- Lana Bader, DClinDent Perio
- Phone Number: +962791200956
- Email: lmbader4@just.edu.jo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Non-smokers
- Systemically healthy
- At least 24 teeth in the functional dentition, excluding third molars
- Clinical diagnosis of periodontal health (no periodontal pockets > 3 mm, bleeding on probing percentage < 10%, and no attachment loss).
Exclusion criteria:
- Smokers.
- Medically compromised patients.
- Pregnant woman.
- Allergies to green tea or EO.
- Any condition that might affect the periodontal tissues.
- Patients with any carious lesions (initial or active).
- Patients who have overhang restorations, poorly designed crowns or bridges, and ortho retainers.
- Use of systemic antibiotics or anti-inflammatory medications within 3 months prior to enrolment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pure Green Tea Mouthwash
Participants in this group will use a mouthwash prepared from pure green tea extract.
The solution will be brewed by infusing 1 g of green tea leaves in 100 ml of boiling deionized water for 20 minutes, cooled, filtered, and stored in brown glass bottles.
|
Participants in this group will use a mouthwash prepared from pure green tea extract.
The solution will be brewed by infusing 1 g of green tea leaves in 100 ml of boiling deionized water for 20 minutes, cooled, filtered, and stored in brown glass bottles.
Participants will rinse with 10 ml of the mouthwash twice daily for 30 seconds over 3 weeks.
They should not use any form of oral hygiene during the study period.
|
|
Active Comparator: Listerine Total Care Mouthwash
Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol.
|
Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol.
All participants will rinse with 10 ml twice daily for 30 seconds for 3 weeks.
They should not use any form of oral hygiene during the study period.
This will serve as an active control to compare the efficacy of essential oils with the pure green tea formulation and placebo.
|
|
Active Comparator: Listerine Green Tea Mouthwash
Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract.
|
Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract and fluoride.
All participants will rinse with 10 ml twice daily for 30 seconds over 3 weeks.
They should not use any form of oral hygiene during the study period.
This will allow comparison between a commercial green tea-containing mouthwash and the pure green tea solution.
|
|
Placebo Comparator: Placebo Mouthwash
The solution contains only water and additive flavor with no active anti-inflammatory ingredients.
|
Participants will rinse with 10 ml of a placebo solution consisting of pure water with a flavored additive to mimic taste and color.
They should not use any form of oral hygiene during the study period.
The solution contains no active anti-inflammatory ingredients.
The placebo serves to determine baseline changes in plaque and gingivitis without active intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turesky modification of the Quigley-Hein plaque index (TM-QHPI)
Time Frame: On days 0, 7, 14, and 21
|
will be recorded at six aspects on each tooth (mesialbuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). 0: No plaque.
|
On days 0, 7, 14, and 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival Index (GI)
Time Frame: On days 0, 7, 14, and 21
|
Gingival inflammation will be evaluated using the Löe & Silness Gingival Index (GI). It will be recorded at six aspects on each tooth (mesialbuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding. |
On days 0, 7, 14, and 21
|
|
The Discoloration Index (DI)
Time Frame: On days 0, 7, 14, and 21
|
will be recorded at six aspects on each tooth (mesialbuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Score 0: No discoloration, clean and polished tooth surface, natural appearance in color. Score1: Slight yellowing discoloration, yellowish film over the entire extent of the clinical crown, slight brownish discoloration along the gingival margin. Score 2: Moderate brownish discoloration on the interproximal surfaces and in the apical third of the clinical crown. Score 3: Heavy brown and black discoloration over the entire extent of the tooth surface, black discoloration predominantly on the interproximal surfaces |
On days 0, 7, 14, and 21
|
|
Patient-reported outcome
Time Frame: On days 7, 14, and 21
|
A self-reported outcome assessing participants' perceived feeling of oral freshness, good breath and cleanliness after using the assigned mouthwash.
Each participant will rate their experience on a Visual Analogue Scale (VAS) from 0 ("not fresh or clean at all") to 10 ("very fresh and clean").
|
On days 7, 14, and 21
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Lana Bader, DClinDent Perio, Jordan University of Science and Technology
- Principal Investigator: Dana Abdullah, MClinDent Perio, Jordan University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 425/2025
- 2025/185-1 (Other Identifier: Institutional Review Board at Jordan University of Science and Technology)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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