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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/185-1 | Other Identifier | Institutional Review Board at Jordan University of Science and Technology |
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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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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:
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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pure Green Tea Mouthwash | Experimental | 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. |
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| Listerine Total Care Mouthwash | Active Comparator | Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol. |
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| Listerine Green Tea Mouthwash | Active Comparator | Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract. |
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| Placebo Mouthwash | Placebo Comparator | The solution contains only water and additive flavor with no active anti-inflammatory ingredients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure Green Tea Mouthwash | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Turesky modification of the Quigley-Hein plaque index (TM-QHPI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index (GI) | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lana Bader, DClinDent Perio | Contact | +962791200956 | lmbader4@just.edu.jo | |
| Dana Adel Abdullah, MClinDent Perio | Contact | +962796653746 | lana.bader@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Lana Bader, DClinDent Perio | Jordan University of Science and Technology | Study Director |
| Dana Abdullah, MClinDent Perio | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology, Faculty of Dentistry | Recruiting | Irbid | Irbid Governorate | 22110 | Jordan |
Individual participant data for plaque index, gingival index, discolouration index, and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participant privacy.
Individual Participant Data (IPD) and supporting documents (Study Protocol, Statistical Analysis Plan, Informed Consent Form, and Clinical Study Report) will be made available after publication of the study results, approximately one year after study completion.
Access will be granted to qualified researchers who request the data via email to the principal investigator. Researchers must sign a data use agreement ensuring ethical use, confidentiality, and prohibition of attempts to identify participants.
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This is a double-blinded, parallel group, randomised, controlled, clinical trial with four arms: pure green tea mouthwash, Listerine Total Care, Listerine Green Tea, and placebo. Participants will rinse twice daily for three weeks. They will be prohibited from all forms of mechanical plaque control during the study period.
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Participants, investigators, and outcome assessors will be blinded. Mouthwashs will be emptied in opaque bottles. They will be coded and unlabeled. A trained dental assisstant will be responsable about disposing the assigned mouth wash to the patient.
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| Listerine Total Care Mouthwash | Drug | 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. |
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| Listerine Green Tea Mouthwash | Drug | 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. |
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| Placebo Mouthwash | Other | 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. |
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| On days 0, 7, 14, and 21 |
| The Discoloration Index (DI) | 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 | 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 |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| D006470 | Hemorrhage |
| D005884 | Gingival Hemorrhage |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006472 | Oral Hemorrhage |
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