Tooth StainNCT07799558
Guided Biofilm Therapy Versus Conventional Polishing for Tooth Re-Staining
A study testing Guided Biofilm Therapy and Conventional Polishing in people with Tooth Stain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study compared Guided Biofilm Therapy with conventional polishing in adults with visible extrinsic tooth staining. Each participant received Guided Biofilm Therapy on one side of the mouth and conventional polishing on the other side. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Stain
- What is being tested?
- Guided Biofilm Therapy and Conventional Polishing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 8 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Willingness to participate in the study and provision of written informed consent.
- Good general health with no systemic disease.
- Clinical presence of extrinsic staining on tooth surfaces at a level warranting professional polishing.
- Right-handed tooth brushing.
- No professional dental cleaning within the previous 6 months.
Who cannot join
- Age under 18 years.
- Diagnosis of periodontitis.
- Current smoking.
- Antibiotic use within the previous 3 months.
- Presence of acute periodontal disease.
- Allergy to polishing powders, specifically erythritol.
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- Presence of a communicable disease.
- Teeth to be measured with restorations, caries, excessive wear, or structural defects that could affect measurement.
- Active orthodontic treatment.
- Developmental or structural anomalies affecting enamel and potentially increasing susceptibility to extrinsic staining, including hypomineralization, amelogenesis imperfecta, or dentinogenesis imperfecta.
- Severe dental crowding preventing standardized measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Biofilm Therapy Versus Conventional Polishing for Extrinsic Tooth Re-Staining, Patient Comfort, and Procedure Time: A Randomized Split-Mouth Trial
This study compared Guided Biofilm Therapy with conventional polishing in adults with visible extrinsic tooth staining. Each participant received Guided Biofilm Therapy on one side of the mouth and conventional polishing on the other side.
The study evaluated whether the two methods differed in the amount of tooth re-staining after treatment, patient discomfort during the procedures, and total procedure time. Tooth color was measured with a spectrophotometer immediately after treatment, at 1 month, and at 2 months. Patient discomfort was recorded using a visual analog scale, and procedure time was measured with a stopwatch.
A total of 34 participants completed the study.
Read the detailed description
This randomized split-mouth clinical trial was conducted in adults with visible extrinsic tooth staining. The aim was to compare Guided Biofilm Therapy (GBT) with conventional polishing in terms of post-procedural extrinsic tooth re-staining, patient discomfort, and procedure time.
Each participant received both interventions. One side of the mouth was assigned to GBT and the contralateral side to conventional polishing. The right-left allocation of the interventions was determined by randomization, with the two allocation sequences equally distributed among participants.
In the GBT intervention, dental biofilm was first disclosed and then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary. In the conventional polishing intervention, supragingival instrumentation was followed by mechanical polishing with a brush and polishing paste.
Tooth color was assessed using a SpectroShade Micro spectrophotometer and the CIELAB color system. Measurements were performed immediately after treatment at baseline (T0), at 1 month (T1), and at 2 months (T2). Color change between assessment periods was calculated using ΔE*ab values.
Patient-reported discomfort was assessed immediately after each half-mouth procedure using a visual analog scale. Total procedure time for each intervention was recorded with a stopwatch.
The primary outcome was color change from immediately after treatment to 2 months. Secondary outcomes included color change from immediately after treatment to 1 month, color change from 1 month to 2 months, patient discomfort, and procedure time.
A total of 34 participants completed all study visits and follow-up assessments.
- Conditions
- Tooth Stain
- Being tested
- Guided Biofilm Therapy, Conventional Polishing
- Keywords
- Guided Biofilm Therapy, Conventional Polishing, Air Polishing, Extrinsic Tooth Staining, Spectrophotometry, Tooth Re-Staining
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Biofilm TherapyProcedure or surgery
Also called GBT
Dental biofilm was first disclosed to guide treatment. Supragingival biofilm and extrinsic staining were then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary, followed by final surface control.
Conventional PolishingProcedure or surgery
Also called CONV
Supragingival instrumentation was performed as needed, followed by mechanical polishing with a prophylaxis brush and polishing paste at 2500 to 3000 rpm. The procedure was completed with final surface control.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Right GBT / Left Conventional Polishing | Experimental | Participants assigned to Sequence A received Guided Biofilm Therapy on the right half of the mouth and conventional polishing on the left half of the mouth. Both interventions were performed within the split-mouth study design. Receives: Procedure: Guided Biofilm Therapy; Procedure: Conventional Polishing |
| Sequence B: Right Conventional Polishing / Left GBT | Experimental | Participants assigned to Sequence B received conventional polishing on the right half of the mouth and Guided Biofilm Therapy on the left half of the mouth. Both interventions were performed within the split-mouth study design. Receives: Procedure: Guided Biofilm Therapy; Procedure: Conventional Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tooth Color From Immediately After Treatment to 2 Months Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between immediately after treatment (T0) and 2 months (T2) was calculated as ΔEab using the formula: ΔEab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). ΔEab is a continuous color-difference measure, with 0 indicating no color difference and higher values indicating greater color change. Therefore, lower ΔEab values indicate greater color stability.
Measured: Immediately after treatment (Day 1) and at 2 months
Secondary outcomes (4)
Change in Tooth Color From Immediately After Treatment to 1 Month Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between immediately after treatment (T0) and 1 month (T1) was calculated as ΔEab using the formula: ΔEab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). ΔEab is a continuous color-difference measure, with 0 indicating no color difference and higher values indicating greater color change. Therefore, lower ΔEab values indicate greater color stability.
Measured: Immediately after treatment (Day 1) and at 1 month
Change in Tooth Color From 1 Month to 2 Months
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between 1 month (M1) and 2 months (M2) was calculated as ΔE*ab using the formula: ΔE*ab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). Lower ΔE*ab values indicate less color change.
Measured: At 1 month and 2 months
Patient-Reported Discomfort Assessed Using a 10-cm Visual Analog Scale
Patient-reported discomfort was assessed immediately after each half-mouth procedure using a 10-cm visual analog scale ranging from 0 to 10, where 0 indicated no discomfort and 10 indicated unbearable discomfort. The score reflected the overall perception of pain or sensitivity, heat, pressure or vibration, and discomfort related to water spray or aerosol. Lower scores indicate greater patient comfort.
Measured: Immediately after completion of each half-mouth intervention (Day 1)
Total Procedure Time Measured Using a Digital Stopwatch
Total procedure time for each intervention was recorded using a digital stopwatch. Timing began with the first clinical step of the relevant intervention and ended after completion of the final surface check. Patient preparation, isolation, and oral hygiene instruction were excluded. Procedure time was recorded in minutes and seconds, with shorter times indicating greater procedural efficiency.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start5 Jan 2026
- Primary completion1 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth StainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- This was a split-mouth study in which each participant received both interventions concurrently. Guided Biofilm Therapy was assigned to one half of the mouth and conventional polishing to the contralateral half. Participants were randomized to one of two right-left allocation sequences.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Tuna, Ataturk University
- Investigators
- Recep Orbak, DDS, PhD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799558
- Sponsor's protocol ID
- 926
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be shared. These data may include participant-level demographic variables, treatment allocation, ΔE\*ab color-change outcomes, visual analog scale scores, and procedure-time data necessary to reproduce the reported analyses.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Biofilm Therapy Versus Conventional Polishing for Extrinsic Tooth Re-Staining, Patient Comfort, and Procedure Time: A Randomized Split-Mouth Trial
- ClinicalTrials.gov ID
- NCT07799558
- Acronym / sponsor ID
- 926
- Conditions
- Tooth Stain
- Keywords
- Guided Biofilm Therapy, Conventional Polishing, Air Polishing, Extrinsic Tooth Staining, Spectrophotometry, Tooth Re-Staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 2 Sep 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 study compared Guided Biofilm Therapy with conventional polishing in adults with visible extrinsic tooth staining. Each participant received Guided Biofilm Therapy on one side of the mouth and conventional polishing on the other side.
The study evaluated whether the two methods differed in the amount of tooth re-staining after treatment, patient discomfort during the procedures, and total procedure time. Tooth color was measured with a spectrophotometer immediately after treatment, at 1 month, and at 2 months. Patient discomfort was recorded using a visual analog scale, and procedure time was measured with a stopwatch.
A total of 34 participants completed the study.
Detailed description
This randomized split-mouth clinical trial was conducted in adults with visible extrinsic tooth staining. The aim was to compare Guided Biofilm Therapy (GBT) with conventional polishing in terms of post-procedural extrinsic tooth re-staining, patient discomfort, and procedure time.
Each participant received both interventions. One side of the mouth was assigned to GBT and the contralateral side to conventional polishing. The right-left allocation of the interventions was determined by randomization, with the two allocation sequences equally distributed among participants.
In the GBT intervention, dental biofilm was first disclosed and then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary. In the conventional polishing intervention, supragingival instrumentation was followed by mechanical polishing with a brush and polishing paste.
Tooth color was assessed using a SpectroShade Micro spectrophotometer and the CIELAB color system. Measurements were performed immediately after treatment at baseline (T0), at 1 month (T1), and at 2 months (T2). Color change between assessment periods was calculated using ΔE*ab values.
Patient-reported discomfort was assessed immediately after each half-mouth procedure using a visual analog scale. Total procedure time for each intervention was recorded with a stopwatch.
The primary outcome was color change from immediately after treatment to 2 months. Secondary outcomes included color change from immediately after treatment to 1 month, color change from 1 month to 2 months, patient discomfort, and procedure time.
A total of 34 participants completed all study visits and follow-up assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a split-mouth study in which each participant received both interventions concurrently. Guided Biofilm Therapy was assigned to one half of the mouth and conventional polishing to the contralateral half. Participants were randomized to one of two right-left allocation sequences.
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Right GBT / Left Conventional Polishing | Experimental | Procedure: Guided Biofilm Therapy, Procedure: Conventional PolishingParticipants assigned to Sequence A received Guided Biofilm Therapy on the right half of the mouth and conventional polishing on the left half of the mouth. Both interventions were performed within the split-mouth study design. |
| Sequence B: Right Conventional Polishing / Left GBT | Experimental | Procedure: Guided Biofilm Therapy, Procedure: Conventional PolishingParticipants assigned to Sequence B received conventional polishing on the right half of the mouth and Guided Biofilm Therapy on the left half of the mouth. Both interventions were performed within the split-mouth study design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years.
- Willingness to participate in the study and provision of written informed consent.
- Good general health with no systemic disease.
- Clinical presence of extrinsic staining on tooth surfaces at a level warranting professional polishing.
- Right-handed tooth brushing.
Key exclusion criteria (11 listed)
- Age under 18 years.
- Diagnosis of periodontitis.
- Current smoking.
- Antibiotic use within the previous 3 months.
- Presence of acute periodontal disease.
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 |
|---|---|---|
| Guided Biofilm TherapyAlso: GBTDental biofilm was first disclosed to guide treatment. Supragingival biofilm and extrinsic staining were then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary, followed by final surface control. | Procedure or surgery | Sequence A: Right GBT / Left Conventional Polishing, Sequence B: Right Conventional Polishing / Left GBT |
| Conventional PolishingAlso: CONVSupragingival instrumentation was performed as needed, followed by mechanical polishing with a prophylaxis brush and polishing paste at 2500 to 3000 rpm. The procedure was completed with final surface control. | Procedure or surgery | Sequence A: Right GBT / Left Conventional Polishing, Sequence B: Right Conventional Polishing / Left GBT |
Primary outcome
Change in Tooth Color From Immediately After Treatment to 2 Months Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Time frame: Immediately after treatment (Day 1) and at 2 months
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between immediately after treatment (T0) and 2 months (T2) was calculated as ΔEab using the formula: ΔEab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). ΔEab is a continuous color-difference measure, with 0 indicating no color difference and higher values indicating greater color change. Therefore, lower ΔEab values indicate greater color stability.
4 secondary outcomes
Change in Tooth Color From Immediately After Treatment to 1 Month Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Time frame: Immediately after treatment (Day 1) and at 1 month
Change in Tooth Color From 1 Month to 2 Months
Time frame: At 1 month and 2 months
Patient-Reported Discomfort Assessed Using a 10-cm Visual Analog Scale
Time frame: Immediately after completion of each half-mouth intervention (Day 1)
Total Procedure Time Measured Using a Digital Stopwatch
Time frame: Periprocedural
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be shared. These data may include participant-level demographic variables, treatment allocation, ΔE*ab color-change outcomes, visual analog scale scores, and procedure-time data necessary to reproduce the reported analyses.
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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.
Recep Orbak, DDS, PhD study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Biofilm Therapy and Conventional Polishing in people with Tooth Stain, run by Ataturk 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 6 inclusion and 11 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 14 Oct 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 in Tooth Color From Immediately After Treatment to 2 Months Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer (time frame: Immediately after treatment (Day 1) and at 2 months). 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 14 Oct 2026.