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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Plaque Index (PI)
時間枠: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)
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score
時間枠: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)
時間枠: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)

協力者と研究者

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出版物と役立つリンク

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月1日

一次修了 (実際)

2024年10月30日

研究の完了 (実際)

2025年2月1日

試験登録日

最初に提出

2026年7月10日

QC基準を満たした最初の提出物

2026年7月10日

最初の投稿 (実際)

2026年7月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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