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Plaque ControlNCT07746128

Plaque-Disclosing Agent for Plaque Control of Gingivitis Patients.

A study testing hree-tone plaque-disclosing agent-assisted oral hygiene instruction in people with Plaque Control and Gingivitis Infection, run by Atlas University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Why was this study done? Gingivitis is the earliest and most common form of gum disease. It develops when dental plaque, a sticky layer of bacteria, builds up on the teeth. Although gingivitis can usually be reversed with good oral hygiene, many people have difficulty removing plaque because it is almost invisible. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Control, Gingivitis Infection
What is being tested?
hree-tone plaque-disclosing agent-assisted oral hygiene instruction
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2026to 23 Jul 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

  • Adults aged 18 years or older. Diagnosis of plaque-induced gingivitis according to the 2018 World Workshop criteria (probing depth ≤3 mm at all sites, no clinical attachment loss, and bleeding on probing ≥10%).
  • No periodontal treatment within the previous 6 months. Ability to read and understand Turkish. Willingness to participate and provision of written informed consent.

Who cannot join

  • Presence of any systemic disease that could affect periodontal health. Pregnancy or lactation. Physical or mental conditions limiting the ability to perform adequate oral hygiene.
  • Use of systemic antibiotics or antiseptic mouthrinses within the previous 3 months.
  • Presence of fixed or removable prosthetic restorations (crowns, bridges, or removable dentures).
  • Withdrawal of consent or discontinuation from the study at any time during the follow-up period.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İstanbul Atlas Üniversitesi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: A Three-Tone Plaque-Disclosing Agent as an Adjunct to Oral Hygiene Instructions in Patients With Gingivitis: A Randomized Controlled Trial

Why was this study done?

Gingivitis is the earliest and most common form of gum disease. It develops when dental plaque, a sticky layer of bacteria, builds up on the teeth. Although gingivitis can usually be reversed with good oral hygiene, many people have difficulty removing plaque because it is almost invisible. Simply telling patients how to brush their teeth may not always be enough to improve daily cleaning habits.

Read more

This study investigated whether using a three-tone plaque-disclosing agent during oral hygiene education could help people with gingivitis remove dental plaque more effectively than standard verbal and written instructions alone.

What did the researchers do?

Sixty-four adults with gingivitis participated in this study. They were randomly assigned to one of two groups. One group received routine oral hygiene instructions, while the other group received the same instructions together with a three-tone plaque-disclosing gel. The gel temporarily stained dental plaque in different colors according to its age and activity, allowing participants to clearly see the areas they had missed during toothbrushing.

The amount of dental plaque was measured before the education session and again three weeks later.

What were the main findings?

Both groups showed improvement in plaque control after three weeks. However, the participants who received visual feedback with the plaque-disclosing gel achieved much greater reductions in dental plaque than those who received standard education alone.

By the end of the study, none of the participants in the plaque-disclosing group had high levels of plaque, whereas about one-third of those in the standard education group still did. These findings suggest that seeing plaque directly on the teeth may help people improve their brushing technique and clean their teeth more thoroughly.

What do these results mean?

This study suggests that plaque-disclosing agents can be a useful educational tool for people with gingivitis. By making plaque visible, they help patients recognize areas that need better cleaning and may encourage more effective daily oral hygiene. Because these products are inexpensive, easy to use, and can be incorporated into routine dental visits, they may provide additional benefits when combined with conventional oral hygiene instructions.

What are the limitations of this study?

The study followed participants for only three weeks, so it cannot determine whether the improvements are maintained over a longer period. In addition, the researchers measured dental plaque but did not reassess gum inflammation after treatment. Therefore, although plaque control improved, this study cannot confirm whether the health of the gums improved to the same extent. Larger studies with longer follow-up are needed to better understand the long-term benefits of this educational approach.

Read the detailed description

Gingivitis is the earliest and most common form of periodontal (gum) disease. It develops when dental plaque, a sticky bacterial biofilm, accumulates on the tooth surfaces because of inadequate oral hygiene. If plaque is not removed regularly, it triggers an inflammatory response in the gums, leading to redness, swelling, and bleeding during brushing or flossing. Unlike periodontitis, gingivitis is reversible when plaque is effectively controlled through good oral hygiene and professional dental care. For this reason, helping individuals improve their daily plaque removal is one of the most important goals of preventive dentistry.

Although most people are aware that they should brush their teeth every day, many do not clean all tooth surfaces effectively. Dental plaque is generally thin, transparent, and difficult to recognize without special aids. As a result, patients may believe they are brushing well while significant amounts of plaque remain on their teeth. Traditional oral hygiene education usually consists of verbal explanations and written instructions. While these methods provide important information, they may not always produce lasting behavioral changes because patients cannot easily identify the areas they consistently miss during brushing.

Plaque-disclosing agents have been developed to overcome this limitation. These products temporarily stain dental plaque, making it clearly visible. The three-tone plaque-disclosing gel used in this study provides additional information by staining plaque in different colors according to its maturity and acid-producing activity. This allows patients to identify not only where plaque is located but also which areas may have been inadequately cleaned for a longer period. Such immediate visual feedback may increase motivation, improve self-awareness, and help patients develop more effective toothbrushing habits.

The purpose of this randomized controlled trial was to determine whether oral hygiene education supported by a three-tone plaque-disclosing agent would improve self-performed plaque control more effectively than conventional oral hygiene education alone in individuals diagnosed with gingivitis.

A total of 64 adults with gingivitis participated in the study. Participants were randomly assigned to one of two groups. The control group received standardized verbal and written oral hygiene instructions together with routine professional dental cleaning. The experimental group received the same treatment, but plaque was first visualized using a three-tone plaque-disclosing gel, allowing participants to see the exact locations where plaque had accumulated before receiving personalized oral hygiene instructions. All participants were re-evaluated three weeks after the initial visit using the Silness-Löe Plaque Index, a widely accepted method for measuring dental plaque.

Both groups demonstrated significant improvements in plaque control after three weeks, indicating that professional cleaning and oral hygiene education are beneficial. However, participants who received visual feedback with the plaque-disclosing agent achieved substantially greater improvements. Their plaque levels decreased much more than those of the control group, and none of the participants in the experimental group remained in the moderate-to-heavy plaque category at the end of the study. In contrast, approximately one-third of participants who received only conventional education still had moderate plaque accumulation.

These findings suggest that visualizing plaque may help patients understand their own oral hygiene deficiencies more effectively than verbal explanations alone. Rather than simply being told where plaque is likely to accumulate, participants could directly observe the areas they had missed during brushing. This personalized visual experience may increase motivation, improve brushing technique, and encourage more consistent oral hygiene behaviors.

For patients and their families, these findings indicate that plaque-disclosing products may be useful educational tools rather than simply diagnostic materials. They can help individuals monitor the effectiveness of their own toothbrushing and identify areas requiring additional attention. Better plaque control may reduce the risk of gingivitis and may contribute to maintaining long-term oral health when combined with regular dental visits and appropriate home care.

For dentists, dental hygienists, and other oral healthcare professionals, the results support incorporating plaque-disclosing agents into routine oral hygiene instruction, particularly for patients with inadequate plaque control or poor brushing technique. These agents are inexpensive, simple to use, non-invasive, and can be easily integrated into everyday clinical practice without increasing treatment complexity.

Several limitations should be considered when interpreting the results. The study followed participants for only three weeks, so the long-term sustainability of the observed improvements remains uncertain. Furthermore, although plaque levels were measured, clinical indicators of gingival inflammation were not reassessed during follow-up. Consequently, while improved plaque control strongly suggests better oral hygiene behavior, this study cannot determine whether these improvements directly resulted in complete resolution of gingival inflammation. Future studies involving larger populations, multiple clinical centers, longer follow-up periods, and additional periodontal outcome measures are needed to confirm the long-term clinical benefits of this educational approach.

Overall, this study demonstrates that combining conventional oral hygiene instruction with a three-tone plaque-disclosing agent provides a practical and effective method for improving plaque control in adults with gingivitis. Because the intervention is simple, affordable, and easily incorporated into routine dental care, it may represent a valuable addition to preventive periodontal practice.

Being tested
hree-tone plaque-disclosing agent-assisted oral hygiene instruction
Keywords
gingivitis, behavior change, oral hygiene instructions
Medical subject headings
Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hree-tone plaque-disclosing agent-assisted oral hygiene instructionOther

    Participants in the intervention group received standardized verbal and written oral hygiene instructions combined with individualized visual feedback using a three-tone plaque-disclosing agent (GC Tri Plaque ID Gel). Before oral hygiene instruction, the disclosing agent was applied to reveal newly formed, mature, and acid-producing dental plaque by different colors, enabling participants to identify inadequately cleaned areas in real time. Following plaque visualization, personalized toothbrushing instructions were provided based on each participant's plaque distribution. In contrast to conventional oral hygiene education, this intervention incorporated immediate visual feedback to improve self-awareness, motivation, and self-performed plaque control.

Study groups in NCT07746128
Study groupRoleWhat they receive
Control GroupNo interventionParticipants received professional supragingival scaling and polishing followed by standardized verbal and written oral hygiene instructions without the use of a plaque-disclosing agent.
Experimental GroupExperimentalarticipants received professional supragingival scaling and polishing followed by standardized verbal and written oral hygiene instructions. In addition, a three-tone plaque-disclosing agent (GC Tri Plaque ID Gel) was applied to provide individualized visual feedback during oral hygiene education.
Receives: Other: hree-tone plaque-disclosing agent-assisted oral hygiene instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Silness-Löe Plaque Index (PI)

    The primary outcome was the change in the mean Silness-Löe Plaque Index from baseline (T0) to the 3-week follow-up (T1). Plaque Index was assessed on the buccal, lingual/palatal, mesial, and distal surfaces of each tooth. Mean plaque scores were calculated for each participant, and the difference between baseline and follow-up values was compared between the experimental and control groups.

    Measured: Baseline and 3 weeks after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start1 Jun 2026
  3. Primary completion23 Jul 2026
  4. Study completion23 Jul 2026

Resources

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
Parallel groups
Model description
This was a single-center, two-arm, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Eligible participants diagnosed with plaque-induced gingivitis were randomly assigned to either the experimental group or the control group. Both groups received professional supragingival scaling and polishing followed by standardized verbal and written oral hygiene instructions. In addition, participants in the experimental group received individualized oral hygiene education supported by a three-tone plaque-disclosing agent (GC Tri Plaque ID Gel), which provided real-time visual feedback on dental plaque accumulation. The control group received no plaque-disclosing agent. The primary outcome was the change in the Silness-Löe Plaque Index from baseline to the 3-week follow-up.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07746128
Sponsor's protocol ID
E-22686390-050.99-93111
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data underlying the results reported in this study (after de-identification) will be made available upon reasonable request to the corresponding author. Data will be shared for scientifically sound research purposes following review and approval of a research proposal and the signing of a data access agreement. Participant confidentiality and institutional ethical requirements will be strictly maintained.

Publications

  • Han S, Kim SJ, Lee T, Jung HI, Lee KE, Song JS. Comparison of the Short Time Effect of an Oral Hygiene Education in Four Sessions via Quantitative Light-Induced Fluorescence Technology Versus Disclosing Agents in Children: A Randomized, Crossover Clinical Trial. Children (Basel). 2024 Nov 12;11(11):1371. doi: 10.3390/children11111371.

    PubMed 39594946
  • Taraç, M., Are Plaque Disclosing Agents Effective for Improving Self-Performed Dental Hygiene in Patients with Space Maintainers? A Randomized Controlled Clinical Trial. Eur. J. Ther, 2024. 30: p. 616-625.

Questions about this trial

What is this clinical trial studying?

A study testing hree-tone plaque-disclosing agent-assisted oral hygiene instruction in people with Plaque Control and Gingivitis Infection, run by Atlas 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 2 inclusion and 4 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 4 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 in the Silness-Löe Plaque Index (PI) (time frame: Baseline and 3 weeks after the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07746128, which also lists 2 linked publications.

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 4 Aug 2026.

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