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Gingivitis and Periodontal DiseasesNCT07706049

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

A study testing Video-Based Oral Hygiene Instruction and Model-Based Oral Hygiene Instruction in people with Gingivitis and Periodontal Diseases and Gingivitis, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Video-Based Oral Hygiene Instruction and Model-Based Oral Hygiene Instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 1 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University Faculty of Dentistry

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Video-Based Oral Hygiene Instruction, Model-Based Oral Hygiene Instruction
Keywords
Gingivitis, oral hyigene instructions, oral health realted self efficiacy
Medical subject headings
Gingivitis, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video-Based Oral Hygiene InstructionBehavioural

    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.

  • Model-Based Oral Hygiene InstructionBehavioural

    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.

Study groups in NCT07706049
Study groupRoleWhat they receive
Video-Based InstructionExperimentalFollowing 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.
Receives: Behavioral: Video-Based Oral Hygiene Instruction
Model-based InstructionActive comparatorFollowing 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.
Receives: Behavioral: Model-Based Oral Hygiene Instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Plaque Index (PI)

    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.

    Measured: Baseline (T0) and 3-Months Follow-up (T1)

  2. Change in Gingival Index (GI)

    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.

    Measured: Baseline (T0) and 3-Months Follow-up (T1)

  3. Change in Bleeding on Probing (BOP) Percentage

    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.

    Measured: Baseline (T0) and 3-Months Follow-up (T1)

Secondary outcomes (2)
  1. Change in Patient-Reported Subjective Gingival Health (VAS)

    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.

    Measured: Baseline (T0) and 3-Months Follow-up (T1)

  2. Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score

    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.

    Measured: Baseline (T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start1 Jun 2024
  3. Primary completion30 Oct 2024
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Following standard Phase 1 periodontal treatment, eligible patients diagnosed with plaque-induced gingivitis are randomly assigned in a 1:1 ratio into two parallel arms. The experimental group receives a standardized video-based oral hygiene instruction, while the active comparator group receives a conventional clinician-demonstrated instruction on a 3D dental model. Both parallel groups are evaluated at baseline(T0) and at a 3-month(T1) follow-up.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706049
Sponsor's protocol ID
2024-08
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Woelber JP, Bienas H, Fabry G, Silbernagel W, Giesler M, Tennert C, Stampf S, Ratka-Kruger P, Hellwig E. Oral hygiene-related self-efficacy as a predictor of oral hygiene behaviour: a prospective cohort study. J Clin Periodontol. 2015 Feb;42(2):142-9. doi: 10.1111/jcpe.12348. Epub 2015 Jan 21.

    PubMed 25472523
  • Syrjala AM, Kneckt MC, Knuuttila ML. Dental self-efficacy as a determinant to oral health behaviour, oral hygiene and HbA1c level among diabetic patients. J Clin Periodontol. 1999 Sep;26(9):616-21. doi: 10.1034/j.1600-051x.1999.260909.x.

    PubMed 10487313

Questions about this trial

What is this clinical trial studying?

A study testing Video-Based Oral Hygiene Instruction and Model-Based Oral Hygiene Instruction in people with Gingivitis and Periodontal Diseases and Gingivitis, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Plaque Index (PI) (time frame: Baseline (T0) and 3-Months Follow-up (T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07706049, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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