NCT07382310

Brief Summary

The goal of this clinical trial is to test if the additional use of different commercially available products for a better breath and plaque reduction, taken during daytime between morning and evening tooth brushing, can reduce the plaque formation of participants during the day. The tested products were:

  • Listerine Total Care mouth rinse without alcohol.
  • Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol.
  • Colgate total advanced pro-shield mouth rinse without alcohol.
  • Listerine Go Tabs.
  • Wrigley Extra White Soft Chew Peppermint chewing gum. The main questions it aims to answer are: Can the tested product lower the plaque formation? Can the tested product improve the mouth freshness and breath? Researchers will compare the tested products to not using any product (controls). Participants need to come for a screening appointment and sign a consent form at first. If they are eligible, they need to come 6 times to the clinic. On each day, they need to come twice (morning appointment at 8 a.m. and evening appointment at 4 p.m.). In the morning, they will have teeth cleaning and recieve one of the tested products to use on that day only (after tea break and lunch break), or they will recieve no product (control day). In the evening, participant's teeth will be stained and oral photos will be taken. They will be asked about their perciption of freshness and good breath after using the product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

January 25, 2026

Last Update Submit

February 9, 2026

Conditions

Dental PlaqueDental Plaque AccumulationMouthwashesChewing Gum

Keywords

Dental plaqueListerine Go tabletListerine Total care mouth washOral B Pro-Health Multi-Protection Mouth RinseColgate total advanced pro-shield mouth rinseWrigley Extra chewing gumxylitol chewing gum

Outcome Measures

Primary Outcomes (1)

  • Plaque index

    Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.

    At the end of each test day (6 days)

Secondary Outcomes (1)

  • Patient reported outcome using visual analoge scale (VAS)

    The VAS was reported by the patients at the end of the assessment day (6 days)

Study Arms (6)

Listerine Total Care mouth rinse without alcohol

ACTIVE COMPARATOR

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Drug: Listerine Total Care mouth rinse without alcohol

Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC)

ACTIVE COMPARATOR

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Drug: Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC)

Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC)

ACTIVE COMPARATOR

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Drug: Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC)

Listerine Go Tabs

ACTIVE COMPARATOR

Participants need to use the tablet twice a day (after tea break and after lunch break) according to manifacturer instructions: chew for 10 seconds to activate, swish around the teeth for 30 seconds to clean then swallow.

Drug: Listerine Go Tabs

Wrigley Extra White Soft Chew Peppermint chewing gum.

ACTIVE COMPARATOR

Participants need to use the chewing gum twice a day (after tea break and after lunch break) for 10 minutes duration.

Drug: Wrigley Extra White Soft Chew Peppermint chewing gum.

Control

NO INTERVENTION

Participants will not recieve any product to use on the control day

Interventions

Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC)DRUG

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC)
Listerine Total Care mouth rinse without alcoholDRUG

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Listerine Total Care mouth rinse without alcohol
Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC)DRUG

Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.

Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC)
Listerine Go TabsDRUG

Participants need to use the tablet twice a day (after tea break and after lunch break) according to manifacturer instructions: chew for 10 seconds to activate, swish around the teeth for 30 seconds to clean then swallow.

Listerine Go Tabs
Wrigley Extra White Soft Chew Peppermint chewing gum.DRUG

Participants need to use the chewing gum twice a day (after tea break and after lunch break) for 10 minutes duration.

Wrigley Extra White Soft Chew Peppermint chewing gum.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age is 18 years or more.
  • Generally healthy.
  • All teeth (28 teeth, excluding 3rd molars) should be present.
  • The absence of untreated caries, secondary caries or faulty restorations.
  • No orthodontic appliances (removable or/and fixed).
  • No oral lesions, no active periodontal disease (no active inflammation or bleeding).
  • Not using a mouthwash or any chewing product in the last week before the beginning of the study.

You may not qualify if:

  • Pregnancy, lactation.
  • Any chronic disease including diabetes, cardiac disease and diseases of the immune system.
  • Presence of signs and symptoms of an acute infection in the oral cavity.
  • Any prescribed systemic or topical medication.
  • Any known allergies against ingredients of the different tested products.
  • Use of antibiotics in the last 3 months.
  • Use of nonsteroidal anti-inflammatory drugs (NSAID) in the last 3 months.
  • History of alcohol or drug abuse.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Dental Hospital (SDH)

Sydney, New South Wales, Central, 2010, Australia

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Ethanolcytidylyl-(3'-5')-cytidine

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Axel Spahr

    University of Sydney

    STUDY DIRECTOR

  • Lana Bader, DClinDent Perio

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All the assessed parameters were measured by one examiner (L.B) who was blinded. A hospital staff member (dental hygienist, F.Z) was responsible for giving the products to the participants. Each participant was given a unique serial identification number composed of two digits. A unique study ID was used to link participants' name, photos, and product used. The hygienist kept a sheet for each participant. On that sheet the following information was recorded: * Unique study ID for each participant. * Participant's first name, surname and date of birth. * Computer generated randomisation list of control and tested products marked as: product A, product B ... etc. * The date when each product was disposed to the participant and the type of product. On each experiment day, a sticker was generated to include the unique ID and the product code that supposed to be received on that day (such as: PPCS 1 Product A, PPCS 2 Product B…etc). It was used to link the oral photos to the unique ID.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover, single blinded, randomised controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

September 18, 2020

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Individual participant data for plaque index (RMNPI) and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participants privacy.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD and supporting documents will be available after publication of the main study results, for a period of one year, starting from the day of research publication.
Access Criteria
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.

Locations

AU(1)