Plaque-Disclosing Agent for Plaque Control of Gingivitis Patients.

NCT07746128 | Completed

• 1 other identifier: E-22686390-050.99-93111
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plaque Control; Gingivitis Infection

Keywords

gingivitis; behavior change; oral hygiene instructions

Outcome Measures

Primary Outcomes (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.

  Baseline and 3 weeks after the intervention.

Study Arms (2)

Control Group

NO INTERVENTION

Participants received professional supragingival scaling and polishing followed by standardized verbal and written oral hygiene instructions without the use of a plaque-disclosing agent.

Experimental Group

EXPERIMENTAL

articipants 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.

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

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

İstanbul Atlas Üniversitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 39594946 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No additional parties were masked. Due to the nature of the intervention, participant blinding was not feasible because the plaque-disclosing agent was visibly applied during oral hygiene instruction. Outcome assessment was also not blinded, as the same investigator performed both the intervention and the clinical plaque index measurements.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: June 1, 2026
• Primary Completion: July 23, 2026
• Study Completion: July 23, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start Date: Upon publication End Date: 5 years after publication
• Access Criteria: Access to de-identified individual participant data will be provided only to qualified researchers whose proposed use of the data has been approved following review of a methodologically sound research proposal. Eligible researchers may access the de-identified individual participant data, the study protocol, and the statistical analysis plan. Requests should be submitted to the corresponding author by email. Data will be shared after execution of a data access agreement and approval by the corresponding author and the host institution, in accordance with applicable ethical and data protection regulations.

Locations

TU (1)