ClinicalTrials.gg
CompletedNCT07799558Updated Oct 14, 2026

Guided Biofilm Therapy Versus Conventional Polishing for Tooth Re-Staining

An interventional study of Guided Biofilm Therapy and Conventional Polishing in Tooth Stain, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Ataturk University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2026, registered Aug 2026).
Updated Oct 14, 2026Study documents postedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Tooth Discoloration with a site in Turkey — 2 open to participants now, 5 under way, none of them phase 3. Tooth Discoloration · Turkey.

Enrollment
9th of 13
34 · median 55
Started
2026
with 1 other
No phase
12 of 17
1 open now
Registered
14th of 17
by date
Lead sponsor
1 of 17
Ataturk University

Among the 17 studies in Tooth Discoloration with a site in Turkey, this one is the 9th largest by enrollment of the 13 interventional ones, is one of 2 that started in 2026, is one of 12 with no phase, and was the 14th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 1 open
Observational4 · 1 open
Phase 41 · 0 open

By the year they started

First in 2016; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 55 across the 13 interventional studies, 42 across the 4 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 17 studies in Tooth Discoloration with a site in Turkey, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Tooth Stain

Browse trials for

Keywords

  • Guided Biofilm Therapy
  • Conventional Polishing
  • Air Polishing
  • Extrinsic Tooth Staining
  • Spectrophotometry
  • Tooth Re-Staining
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age over 18 years.
  • Willingness to participate in the study and provision of written .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Sequence A: Right GBT / Left Conventional Polishing

    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.

    Procedure: Guided Biofilm Therapy · Procedure: Conventional Polishing

  • Experimental
    Sequence B: Right Conventional Polishing / Left GBT

    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.

    Procedure: Guided Biofilm Therapy · Procedure: Conventional Polishing

Interventions

  • ProcedureGuided Biofilm Therapy

    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.

    Also known as: GBT

  • ProcedureConventional Polishing

    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.

    Also known as: CONV

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after treatment (Day 1) and at 2 months

Secondary outcomes

  1. 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.

    Time frame: Immediately after treatment (Day 1) and at 1 month

  2. 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.

    Time frame: At 1 month and 2 months

  3. 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.

    Time frame: Immediately after completion of each half-mouth intervention (Day 1)

  4. 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.

    Time frame: Periprocedural

07

Study locations

1 site
  • Atatürk University
    Erzurum, Erzurum 25080, Turkey (Türkiye)
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Time frame: Data and supporting information will be available beginning 6 months after publication of the study results and will remain available for 5 years.

Access criteria: Qualified researchers may request access from the corresponding author for scientifically justified research purposes. Requests should include a brief research proposal describing the purpose of the analysis and the data requested. Access will be considered following review of the proposed use and applicable ethical and confidentiality requirements. Only de-identified data relevant to the approved request will be shared electronically.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Jun 2026, 4 months.

Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 4 months is below that.

Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 2, 2026
StartActual
Jan 5, 2026
Primary completionActual
Jun 1, 2026
CompletionActual
Jun 8, 2026
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Documents
Show all 1 update
  1. Oct 14, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07799558
Lead sponsor
Ataturk University
Responsible party
Mehmet Ali Tuna (DDS, Ataturk University) — Principal investigator
First posted
Sep 2, 2026
Start date
Jan 5, 2026
Primary completion
Jun 1, 2026
Completion
Jun 8, 2026
Last update
Oct 14, 2026

Study contacts

Recep Orbak, DDS, PhD
study director · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion