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Trial registered on ANZCTR


Registration number
ACTRN12619000359134
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
6/03/2019
Date last updated
12/02/2020
Date data sharing statement initially provided
6/03/2019
Date results information initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient acceptance of a green tea-based mouth rinse
Scientific title
Tolerability of a Green Tea-Based Mouth Rinse in healthy volunteers: A Randomized, Open-Label Clinical Trial
Secondary ID [1] 297577 0
None
Universal Trial Number (UTN)
U1111-1229-3546
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingival disease 311834 0
Condition category
Condition code
Oral and Gastrointestinal 310473 310473 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313808 0
Treatment: Drugs
Comparator / control treatment
Rinse with chlorhexidine gluconate using 10 ml undiluted solution for 1 minutes twice a day
Control group
Active

Outcomes
Primary outcome [1] 319299 0
This will be a composite outcome assessment. Subjective tolerability measured through mouth burning sensation, mouth dryness, mouth pain, and dental sensitivity using a scale of 1 – 10 (1 indicates the lowest level and 10 indicates the highest level), malodor using yes/no question. In addition to taste sensation (1 – 10 scale) and texture of the mouth wash
Timepoint [1] 319299 0
14 days after initiation of treatment
Secondary outcome [1] 367624 0
This will be a composite outcome assessment. Objective tolerability though assessment of the oral tissues for erythema, ulceration, desquamation and chronic bite injury.
Study PI will be assessing the oral tissues using a mirror, light and clinical features.
Timepoint [1] 367624 0
14 days after initiation of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21320 0
Saudi Arabia
State/province [1] 21320 0
Jeddah

Funding & Sponsors
Funding source category [1] 302125 0
Self funded/Unfunded
Name [1] 302125 0
Hani Mawardi
Address [1] 302125 0
King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia
Country [1] 302125 0
Saudi Arabia
Primary sponsor type
Individual
Name
Hani Mawardi
Address
King Abdulaziz University - Faculty of Dentistry
Jeddah, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 301962 0
None
Name [1] 301962 0
Address [1] 301962 0
Country [1] 301962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302805 0
Research ethics committee at King Abdulaziz University - Faculty of Dentistry
Ethics committee address [1] 302805 0
King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia
Ethics committee country [1] 302805 0
Saudi Arabia
Date submitted for ethics approval [1] 302805 0
01/07/2018
Approval date [1] 302805 0
16/09/2018
Ethics approval number [1] 302805 0
054-04-18

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91462 0
Dr Hani Mawardi
Address 91462 0
King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia
Country 91462 0
Saudi Arabia
Phone 91462 0
+966505351343
Fax 91462 0
Email 91462 0
hmawardi@kau.edu.sa
Contact person for public queries
Name 91463 0
Dr Hani Mawardi
Address 91463 0
King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia
Country 91463 0
Saudi Arabia
Phone 91463 0
+966505351343
Fax 91463 0
Email 91463 0
hmawardi@kau.edu.sa
Contact person for scientific queries
Name 91464 0
Dr Hani Mawardi
Address 91464 0
King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia
Country 91464 0
Saudi Arabia
Phone 91464 0
+966505351343
Fax 91464 0
Email 91464 0
hmawardi@kau.edu.sa

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1481 0
Ethical approval
Citation [1] 1481 0
Link [1] 1481 0
Email [1] 1481 0
Other [1] 1481 0
Type [2] 1482 0
Study protocol
Citation [2] 1482 0
Link [2] 1482 0
Email [2] 1482 0
Other [2] 1482 0
Type [3] 1483 0
Informed consent form
Citation [3] 1483 0
Link [3] 1483 0
Email [3] 1483 0
Other [3] 1483 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary