Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients (NCT07706049) | Clinical Trial Compass
CompletedNot Applicable
Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients
Turkey (Türkiye)80 participantsStarted 2024-06-01
Plain-language 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. 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 one-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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Plaque Index (PI)
Timeframe: Baseline (T0) and 1-Month Follow-up (T1)
2
Change in Gingival Index (GI)
Timeframe: Baseline (T0) and 1-Month Follow-up (T1)
3
Change in Bleeding on Probing (BOP) Percentage
Timeframe: Baseline (T0) and 1-Month Follow-up (T1)