ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

U1111-1229-3546

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gingival disease

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

14 days after initiation of treatment

Secondary outcome [1]

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]

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

Sex

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

1/04/2019

Actual

1/04/2019

Date of last participant enrolment

Anticipated

Actual

1/06/2019

Date of last data collection

Anticipated

Actual

6/07/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Saudi Arabia

State/province [1]

Jeddah

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Hani Mawardi

Address [1]

King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research ethics committee at King Abdulaziz University - Faculty of Dentistry

Ethics committee address [1]

King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia

Ethics committee country [1]

Saudi Arabia

Date submitted for ethics approval [1]

01/07/2018

Approval date [1]

16/09/2018

Ethics approval number [1]

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

Dr Hani Mawardi

Address

King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia

Country

Saudi Arabia

Phone

+966505351343

Fax

[email protected]

Contact person for public queries

Name

Hani Mawardi

Address

King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia

Country

Saudi Arabia

Phone

+966505351343

Fax

[email protected]

Contact person for scientific queries

Name

Hani Mawardi

Address

King Abdulaziz University - Faculty of Dentistry
Abdullah Alsuliman street
P.O. Box : 80200
Zip Code : 21589
Jeddah, Saudi Arabia

Country

Saudi Arabia

Phone

+966505351343

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
1481	Ethical approval	377101-(Uploaded-28-02-2019-18-42-04)-Study-related document.PDF
1482	Study protocol	377101-(Uploaded-28-02-2019-18-42-22)-Study-related document.docx
1483	Informed consent form	377101-(Uploaded-28-02-2019-18-42-37)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically