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临床试验/NCT07746128
NCT07746128已完成不适用

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

Atlas University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Change in the Silness-Löe Plaque Index (PI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in the Silness-Löe Plaque Index (PI)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Arpaci

Research Assistant

Atlas University

研究点 (1)

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