About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Smokers.
Medically compromised patients.
Pregnant woman.
Allergies to green tea or EO.
Trial design
Parallel
Treatments tested in this trial
Pure Green Tea Mouthwash
DrugParticipants 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.
Listerine Total Care Mouthwash
DrugParticipants 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.
Listerine Green Tea Mouthwash
DrugParticipants 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 Mouthwash
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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. 1. Separate flecks of plaque at the gumline (cervical margin). 2. A thin, continuous band (up to 1 mm) at the gumline. 3. A band wider than 1 mm but covering less than one-third of the tooth crown. 4. Plaque covering one-third to two-thirds of the crown. 5. Plaque covering two-thirds or more of the crown.
Secondary outcomes
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.
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
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").
Sponsors and contacts
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King Abdullah University Hospital
Lead sponsor
Jordan University of Science and Technology
Sponsor institution
Jordan University of Science and Technology
Collaborator