Tongue CoatingNCT07767721
Comparison of Three Tongue Cleaners for Removing Tongue Coating
A study testing Bristled tongue brush, Plastic tongue scraper and Metal tongue scraper in people with Tongue Coating and Oral Biofilm, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
Trial summary
This randomised three-period crossover study compared the effectiveness of three tongue-cleaning devices - a bristled tongue brush, a plastic tongue scraper and a metal tongue scraper - in removing tongue biofilm. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tongue Coating, Oral Biofilm, Oral Hygiene
- What is being tested?
- Bristled tongue brush, Plastic tongue scraper and Metal tongue scraper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 7 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 25 years
- No professional dental cleaning within the previous two weeks
- Willing to maintain usual toothbrushing and interdental hygiene practices throughout the study period
Who cannot join
- -History of significant systemic disease (e.g. diabetes mellitus, immune disorders)
- Clinical salivary gland dysfunction or self-reported xerostomia
- Active oral or mucosal infection (e.g. severe periodontitis, extensive caries)
- Active mucosal lesions
- Fixed orthodontic appliances
- Conditions predisposing to severe gagging beyond normal clinical sensitivity
- Use of topical or systemic antimicrobials or antibiotics within the previous month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kent University, Faculty of Dentistry
Istanbul
About this study
Official title: Investigation Into the Effectiveness of Tongue Cleaning With Different Materials Using Visual and Fluorescence Methods
This randomised three-period crossover study compared the effectiveness of three tongue-cleaning devices - a bristled tongue brush, a plastic tongue scraper and a metal tongue scraper - in removing tongue biofilm. Thirty healthy volunteers aged 18 to 30 used each device once daily for 14 consecutive days, with 7-day washout periods between devices during which no tongue cleaning was performed. Tongue biofilm was measured objectively by Quantitative Light-induced Fluorescence-Digital (QLF-D) imaging, alongside the visual Tongue Coating Index, salivary pH, and participant-reported acceptability including gag reflex.
- Conditions
- Tongue Coating, Oral Biofilm, Oral Hygiene, Dental Plaque
- Being tested
- Bristled tongue brush, Plastic tongue scraper, Metal tongue scraper
- Keywords
- QLF-D, tongue scraper, tongue brush, Delta F, Tongue Coating Index, crossover
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bristled tongue brushDevice
Over-the-counter tongue brush with a bristled cleaning surface (R.O.C.S. Pro Lingua, Moscow, Russia). Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort.
Plastic tongue scraperDevice
Over-the-counter smooth plastic tongue scraper (Pearldent, DentaRAM, Istanbul, Türkiye). Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort.
Metal tongue scraperDevice
Over-the-counter rigid metal tongue scraper (Glimo, Haltron, Istanbul, Türkiye).
Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Bristled Brush → Plastic Scraper → Metal Scraper | Experimental | Device: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days.
Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen.
Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen.
All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. Receives: Device: Bristled tongue brush; Device: Plastic tongue scraper; Device: Metal tongue scraper |
| Sequence 2: Plastic Scraper → Metal Scraper → Bristled Brush | Experimental | Device: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days.
Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen.
Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen.
All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. Receives: Device: Bristled tongue brush; Device: Plastic tongue scraper; Device: Metal tongue scraper |
| Sequence 3: Metal Scraper → Bristled Brush → Plastic Scraper | Experimental | Device: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days.
Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen.
Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen.
All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. Receives: Device: Bristled tongue brush; Device: Plastic tongue scraper; Device: Metal tongue scraper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Maximum Fluorescence Loss (Delta F Max) of Tongue Dorsum Biofilm Assessed by Quantitative Light-Induced Fluorescence-Digital (QLF-D) Imaging
Measured: Baseline (Day 1), Day 7 and Day 14 of each 14-day intervention period
Secondary outcomes (8)
Change From Baseline in Average Fluorescence Loss (Delta F Average)
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Total Fluorescence Loss (Delta Q)
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in White Spot Area
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in White Spot Delta R
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Tongue Coating Index (TCI)
The tongue dorsum is divided into nine regions (three posterior, three middle, three anterior). Each region is scored for coating thickness (0 = no coating,
- = thin, 2 = thick) and for discolouration (0 = none, 1 = white,
- = yellow/light brown, 3 = brown), following Shimizu et al. Higher scores indicate a greater quantity of tongue coating.
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Unstimulated Salivary pH
Unstimulated whole saliva collected with participants seated after refraining from eating and drinking for at least 60 minutes. Measured immediately with MQuant pH indicator strips (Merck KGaA, Darmstadt, Germany); the median of two readings was recorded.
Measured: Baseline (Day 1), Day 7 and Day 14 of each period
Participant-Reported Device Acceptability
Measured: End of study (Day 14 of the third period)
Participant-Reported Gag Reflex Severity
Measured: End of study (Day 14 of the third period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 May 2025
- Primary completion7 Sep 2025
- Study completion7 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue CoatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Şahin, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767721
- Sponsor's protocol ID
- IKU-DENT-TONGUE-01
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the published results (QLF-D parameters, Tongue Coating Index scores, salivary pH values and questionnaire responses) will be made available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Effectiveness of Tongue Cleaning With Different Materials Using Visual and Fluorescence Methods
- ClinicalTrials.gov ID
- NCT07767721
- Acronym / sponsor ID
- IKU-DENT-TONGUE-01
- Conditions
- Tongue Coating, Oral Biofilm, Oral Hygiene, Dental Plaque
- Keywords
- QLF-D, tongue scraper, tongue brush, Delta F, Tongue Coating Index, crossover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 7 Sep 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised three-period crossover study compared the effectiveness of three tongue-cleaning devices - a bristled tongue brush, a plastic tongue scraper and a metal tongue scraper - in removing tongue biofilm. Thirty healthy volunteers aged 18 to 30 used each device once daily for 14 consecutive days, with 7-day washout periods between devices during which no tongue cleaning was performed. Tongue biofilm was measured objectively by Quantitative Light-induced Fluorescence-Digital (QLF-D) imaging, alongside the visual Tongue Coating Index, salivary pH, and participant-reported acceptability including gag reflex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Bristled Brush → Plastic Scraper → Metal Scraper | Experimental | Device: Bristled tongue brush, Device: Plastic tongue scraper, Device: Metal tongue scraperDevice: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days. Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen. Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen. All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. |
| Sequence 2: Plastic Scraper → Metal Scraper → Bristled Brush | Experimental | Device: Bristled tongue brush, Device: Plastic tongue scraper, Device: Metal tongue scraperDevice: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days. Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen. Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen. All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. |
| Sequence 3: Metal Scraper → Bristled Brush → Plastic Scraper | Experimental | Device: Bristled tongue brush, Device: Plastic tongue scraper, Device: Metal tongue scraperDevice: Bristled tongue brush R.O.C.S. Pro Lingua (Moscow, Russia). Over-the-counter tongue brush with a bristled cleaning surface, used once daily on the tongue dorsum for 14 consecutive days. Device: Plastic tongue scraper Pearldent (DentaRAM, Istanbul, Türkiye). Same regimen. Device: Metal tongue scraper Glimo (Haltron, Istanbul, Türkiye). Same regimen. All devices: single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 18 to 25 years
- No professional dental cleaning within the previous two weeks
- Willing to maintain usual toothbrushing and interdental hygiene practices throughout the study period
Key exclusion criteria (7 listed)
- -History of significant systemic disease (e.g. diabetes mellitus, immune disorders)
- Clinical salivary gland dysfunction or self-reported xerostomia
- Active oral or mucosal infection (e.g. severe periodontitis, extensive caries)
- Active mucosal lesions
- Fixed orthodontic appliances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bristled tongue brushOver-the-counter tongue brush with a bristled cleaning surface (R.O.C.S. Pro Lingua, Moscow, Russia). Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. | Device | Sequence 1: Bristled Brush → Plastic Scraper → Metal Scraper, Sequence 2: Plastic Scraper → Metal Scraper → Bristled Brush, Sequence 3: Metal Scraper → Bristled Brush → Plastic Scraper |
| Plastic tongue scraperOver-the-counter smooth plastic tongue scraper (Pearldent, DentaRAM, Istanbul, Türkiye). Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. | Device | Sequence 1: Bristled Brush → Plastic Scraper → Metal Scraper, Sequence 2: Plastic Scraper → Metal Scraper → Bristled Brush, Sequence 3: Metal Scraper → Bristled Brush → Plastic Scraper |
| Metal tongue scraperOver-the-counter rigid metal tongue scraper (Glimo, Haltron, Istanbul, Türkiye). Participants used the device once daily for 14 consecutive days, performing a single-directional sweeping motion from the posterior vallate papillae to the anterior tip of the tongue dorsum, using gentle self-regulated pressure sufficient to alter tissue curvature without causing mucosal discomfort. | Device | Sequence 1: Bristled Brush → Plastic Scraper → Metal Scraper, Sequence 2: Plastic Scraper → Metal Scraper → Bristled Brush, Sequence 3: Metal Scraper → Bristled Brush → Plastic Scraper |
Primary outcome
Change From Baseline in Maximum Fluorescence Loss (Delta F Max) of Tongue Dorsum Biofilm Assessed by Quantitative Light-Induced Fluorescence-Digital (QLF-D) Imaging
Time frame: Baseline (Day 1), Day 7 and Day 14 of each 14-day intervention period
8 secondary outcomes
Change From Baseline in Average Fluorescence Loss (Delta F Average)
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Total Fluorescence Loss (Delta Q)
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in White Spot Area
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in White Spot Delta R
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Tongue Coating Index (TCI)
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Change From Baseline in Unstimulated Salivary pH
Time frame: Baseline (Day 1), Day 7 and Day 14 of each period
Participant-Reported Device Acceptability
Time frame: End of study (Day 14 of the third period)
Participant-Reported Gag Reflex Severity
Time frame: End of study (Day 14 of the third period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the published results (QLF-D parameters, Tongue Coating Index scores, salivary pH values and questionnaire responses) will be made available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bristled tongue brush, Plastic tongue scraper and Metal tongue scraper in people with Tongue Coating and Oral Biofilm, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Maximum Fluorescence Loss (Delta F Max) of Tongue Dorsum Biofilm Assessed by Quantitative Light-Induced Fluorescence-Digital (QLF-D) Imaging (time frame: Baseline (Day 1), Day 7 and Day 14 of each 14-day intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.