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Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients

2026年9月8日 更新者:İlkim Karadağ、Ankara University

Comparison of Video-Based Versus Model-Based Oral Hygiene Instruction on Clinical Outcomes and the Predictive Role of Self-Efficacy in Gingivitis Patients: A Single-Blind Randomized Clinical Trial

This randomized, single-blind clinical trial aims to evaluate the short-term effectiveness of two different oral hygiene instruction (OHI) methods-video-assisted instruction versus traditional 3D model demonstration-on periodontal clinical parameters in patients diagnosed with gingivitis. A critical secondary objective of this study is to investigate the predictive role of patients' baseline Oral Hygiene-Related Self-Efficacy (OHSE) on the extent of clinical healing, and to assess changes in patient-reported subjective gingival health using a Visual Analogue Scale (VAS). A total of 80 patients undergoing standard Phase 1 periodontal therapy (scaling and root planing) are randomly assigned in a 1:1 ratio to either the video instruction group or the model instruction group. Periodontal clinical indices, including Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing (BOP), alongside patient-reported outcomes, are recorded at baseline and at a three-month follow-up by a blinded examiner. The primary hypothesis is that video-based instruction is non-inferior to conventional model-based instruction in improving clinical parameters. Furthermore, the study hypothesizes that a patient's baseline self-efficacy level-independent of the educational method received-significantly predicts the reduction in periodontal inflammation and bleeding scores.

研究概览

详细说明

Background and Rationale Gingivitis is a reversible inflammatory condition of the gingival tissues caused by the accumulation of dental plaque. The gold standard for its prevention and treatment is professional mechanical plaque removal (Phase 1 periodontal therapy) combined with effective, daily supragingival plaque control by the patient. However, maintaining long-term patient compliance and motivation remains a significant clinical challenge. Traditionally, oral hygiene instruction (OHI) involves verbal guidance and practical demonstration of brushing and interdental cleaning techniques on 3D dental models. With the integration of digital health technologies, video-based educational tools have emerged as a viable alternative. Video instructions offer standardized content and optimize the clinician's chair-time, which is highly valuable in busy clinical settings. While clinical indices objectively measure disease severity, contemporary periodontal care increasingly recognizes the crucial role of psychological and behavioral factors in treatment success. Oral hygiene-related self-efficacy (OHSE)-a patient's belief in their ability to maintain oral care habits even under taxing situations-is a key cognitive determinant of behavior change. Therefore, evaluating clinical outcomes in conjunction with OHSE and Patient-Reported Outcome Measures (PROMs) provides a more comprehensive understanding of periodontal healing dynamics.

Study Objectives The primary objective of this study is to compare the short-term clinical efficacy of video-based versus model-based OHI delivered as an adjunct to Phase 1 periodontal treatment in patients with gingivitis. The secondary objective is to evaluate whether patients' baseline OHSE scores predict the amount of clinical improvement (reductions in Plaque Index and Bleeding on Probing) and to assess changes in self-reported gingival symptoms using a Visual Analogue Scale (VAS).

Methodology and Study Design This study is designed as a prospective, randomized, single-blind, parallel-group clinical trial conducted at Ankara University Faculty of Dentistry. The trial enrolls 80 eligible patients diagnosed with plaque-induced gingivitis, characterized by a whole-mouth average Gingival Index (GI) > 2.0 and no probing depths > 4 mm. Patients with a history of systemic diseases affecting periodontal tissues, current smokers, and those who received antibiotic therapy within the last 3 months are excluded.

Clinical and Behavioral Assessments Prior to any intervention (Baseline - T0), a blinded examiner assesses the periodontal health of the participants using the Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing (BOP) at six sites per tooth. Following the clinical examination, patients complete a validated Oral Hygiene-Related Self-Efficacy (OHSE) questionnaire, which evaluates their confidence in performing toothbrushing, interdental cleaning, and regular dental visits under various psychological barriers. Additionally, patients rate their subjective gingival symptoms (e.g., bleeding, swelling, bad breath) using a 10-point VAS. Intervention Following baseline assessments, all patients receive standard Phase 1 periodontal treatment, consisting of full-mouth supragingival and subgingival scaling and polishing using ultrasonic instruments and hand curettes. Immediately after the mechanical therapy, patients are randomly allocated to one of two groups (1:1 ratio): Video Group: Patients receive a digital link to a standardized instructional video demonstrating proper toothbrushing and interdental cleaning techniques. Model Group: Patients receive one-on-one practical oral hygiene instruction demonstrated by a clinician on a 3D dental model.

Follow-up and Statistical Analysis Patients are recalled at 3 month (T1) post-intervention. The same blinded examiner repeats all clinical measurements (PI, GI, PD, BOP) and patients re-evaluate their subjective gingival symptoms (VAS). Statistical analyses will be performed to assess within-group and between-group variations. The comparison of clinical improvement amounts (Δ T0 - T1) between the Video and Model groups will be conducted using Independent Samples t-tests and Analysis of Covariance (ANCOVA), adjusting for baseline clinical values and initial OHSE scores. Correlation analyses will be employed to examine the predictive relationship between baseline OHSE subsets (particularly interdental cleaning self-efficacy) and objective reductions in periodontal inflammation.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients officially diagnosed with plaque-induced gingivitis.
  • Patients having an average whole-mouth Gingival Index (GI) score strictly above 2.0 at baseline.
  • Patients aged between 18 and 65 years.
  • Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

  • Individuals with an average whole-mouth Gingival Index (GI) score of 2.0 or below.
  • Individuals presenting with periodontal pockets deeper than 4 mm in any single area of the mouth.
  • Individuals who possess fixed prosthetic restorations on any tooth.
  • Individuals who have received any form of professional periodontal treatment within the last 6 months.
  • Individuals who currently smoke or use similar tobacco products.
  • Individuals who have used systemic antibiotics for any medical or dental reason within the last 3 months.
  • Individuals who are physically or cognitively unable to perform adequate daily oral hygiene practices.
  • Individuals who have lost 5 or more natural teeth (excluding third molars/wisdom teeth).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Video-Based Instruction
Following standard Phase 1 periodontal treatment (full-mouth supragingival and subgingival scaling and polishing), patients assigned to this arm receive their oral hygiene instruction via a digital video platform.
Patients are provided with a digital link to a standardized, audio-visual instructional video. The video comprehensively demonstrates proper toothbrushing and interdental cleaning techniques. Patients are instructed to watch the video and use it as a reference to reinforce their daily oral home care routine.
有源比较器:Model-based Instruction
Following standard Phase 1 periodontal treatment (full-mouth supragingival and subgingival scaling and polishing), patients assigned to this arm receive conventional oral hygiene instruction demonstrated directly by a clinician.
A clinician provides a one-on-one, hands-on practical demonstration of proper toothbrushing and interdental cleaning techniques. This instruction is delivered interactively using a 3-dimensional physical dental model to guide and educate the patient on their daily oral home care routine.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Plaque Index (PI)
大体时间:Baseline (T0) and 3-Months Follow-up (T1)
The Plaque Index evaluates the level of dental plaque accumulation. Measurements are taken by a blinded examiner at six sites per tooth (mesio-facial, mid-facial, disto-facial, mesio-oral, mid-oral, and disto-oral). The whole-mouth average score is calculated for each patient. A decrease in the score represents an improvement in oral hygiene and plaque control.
Baseline (T0) and 3-Months Follow-up (T1)
Change in Gingival Index (GI)
大体时间:Baseline (T0) and 3-Months Follow-up (T1)
The Gingival Index assesses the severity of gingival inflammation. Measurements are recorded by a blinded examiner at six sites per tooth. The whole-mouth average score is calculated. A decrease in the score indicates a reduction in gingival inflammation and clinical improvement.
Baseline (T0) and 3-Months Follow-up (T1)
Change in Bleeding on Probing (BOP) Percentage
大体时间:Baseline (T0) and 3-Months Follow-up (T1)
Bleeding on Probing assesses the presence or absence of gingival bleeding stimulated by a periodontal probe. It is evaluated at six sites per tooth. The outcome is calculated as the percentage of bleeding sites relative to the total number of sites evaluated. A decrease in the percentage indicates reduced inflammation and clinical healing.
Baseline (T0) and 3-Months Follow-up (T1)

次要结果测量

结果测量
措施说明
大体时间
Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score
大体时间:Baseline (T0)
The validated OHSE questionnaire evaluates a patient's internal confidence in performing oral hygiene tasks (toothbrushing, interdental cleaning, and attending dental visits) under taxing situations. It consists of 19 items rated on a 4-point Likert scale (1 = "completely confident not to", 4 = "completely confident"). The total score ranges from 19 to 76. Higher scores indicate greater psychological resilience and self-efficacy. This is measured prior to intervention to serve as an independent predictive variable for clinical healing.
Baseline (T0)
Change in Patient-Reported Subjective Gingival Health (VAS)
大体时间:Baseline (T0) and 3-Months Follow-up (T1)
Patients evaluate their subjective perception of their own gingival health and symptoms (such as bleeding, swelling, or bad breath) using a 10-point Visual Analogue Scale (VAS). The scores range from 1 to 10, where 1 indicates "very poor" and 10 indicates "excellent". An increase in the score represents an improvement in the patient's subjective perception of their gingival health.
Baseline (T0) and 3-Months Follow-up (T1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月1日

初级完成 (实际的)

2024年10月30日

研究完成 (实际的)

2025年2月1日

研究注册日期

首次提交

2026年7月10日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All collected de-identified individual participant data (IPD) that underlie the results reported in the final published article will be shared. This includes demographic data, clinical periodontal indices (PI, GI, PD, BOP), and patient-reported outcome measures (OHSE and VAS scores).

IPD 共享时间框架

Data will be available beginning 6 months and ending 36 months following the publication of the article.

IPD 共享访问标准

Data will be shared with researchers who provide a methodologically sound proposal for the purpose of achieving the specific aims outlined in their approved proposal. Requests should be directed to the corresponding author via email.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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