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Completed

NCT Number: NCT07746128

Plaque-Disclosing Agent for Plaque Control of Gingivitis Patients.

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Atlas Üniversitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

hree-tone plaque-disclosing agent-assisted oral hygiene instruction

Other

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.

Primary outcomes

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

    Time frame: Baseline and 3 weeks after the intervention.

    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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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