None listed
Conditions
Brief summary
Tolerability of mouth rinses (with- or without alcohol) may differ between patients. As such, tolerability assessment plays a role in patient compliance with mouth rinse therapy. Listerine with green tea mouth rinse is a recently introduced in the market here in Saudi Arabia. Due to the health effects of green tea and the antioxidant features, it might be attractive for users. Hence, the aim of this study is to evaluate the tolerability of none alcohol containing Listerine with green tea mouth rinse (commercially available) compared to chlorhexidine mouth. This is an unblinded randomized clinical trial to be conducted at King Abdul-Aziz University Faculty of Dentistry on healthy volunteers. Study Subjects will be assigned randomly to either group A of none-alcohol containing Listerine® with green tea or group B of chlorhexidine gluconate mouth rinse. According to the manufacture instructions, Listerine® with green tea group will be instructed to use 20 ml of the rinse, undiluted for 30 seconds twice a day, and chlorhexidine mouth rinse group will be instructed to use 10m of the rinse for 1 mints twice a day. All study subjects will be instructed to use the rinse following their daily oral hygiene routine and avoid eating and drinking for 30 minutes afterword. Date collection will include demographic data (e.g. age, gender etc), smoking history, allergy history, history of mouth burning sensation, mouth dryness, malodor, history of mouth pain, history of any dental sensitivity, and history of change in taste sensation using scale from (1-10) (one was the lowest and 10 was the highest). Other collected data will include texture of the mouth wash using theses option (Too thick, too thin (watery), Good), the subject opinion about the mouth wash whether they like it or not and change in taste after using the mouth rinses was recorded using scale from (9 point hedonic scale for assessment of taste and smell). All subjects will have intraoral examination for a group of parameters including erythema, ulcer, desquamation and chronic bite injury to completed in two points of time at day 0 and at day 14.
Interventions
Rinse with Listerine® with green tea using 20 ml undiluted solution for 30 seconds twice a day for 14 days. In order to monitor subject compliance, unused product will be returned to study PI.
Sponsors
Hani Mawardi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
healthy subjects who are 18 years or older and had not been using any oral rinses (including fluoride or bleaching rinse) for the past 2 weeks. In addition, study subjects should have stable oral condition with no pain at baseline.
Exclusion criteria
Subjects with allergy to any component of the study mouth rinses, pregnant or lactating women, subjects with current alcohol consumption, recent periodontal surgery or extraction (at least for the past 3 months), taking any analgesics, participating in any other clinical trial (at least for the past 30 days), and regularly using any other mouth rinse.
Outcome results
None listed