- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07706049
Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Ankara University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
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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).
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Plaque Index (PI)
Time Frame: Baseline (T0) and 1-Month Follow-up (T1)
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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.
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Baseline (T0) and 1-Month Follow-up (T1)
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Change in Gingival Index (GI)
Time Frame: Baseline (T0) and 1-Month Follow-up (T1)
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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.
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Baseline (T0) and 1-Month Follow-up (T1)
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Change in Bleeding on Probing (BOP) Percentage
Time Frame: Baseline (T0) and 1-Month Follow-up (T1)
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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.
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Baseline (T0) and 1-Month Follow-up (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Patient-Reported Subjective Gingival Health (VAS)
Time Frame: Baseline (T0) and 1-Month Follow-up (T1)
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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.
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Baseline (T0) and 1-Month Follow-up (T1)
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Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score
Time Frame: Baseline (T0)
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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.
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Baseline (T0)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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