- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07479706
Impact of Oral Hygiene Instruction in Gingivitis Patients
Impact of Video-Based Versus Model-Based Oral Hygiene Instruction on Clinical Parameters and Disease Awareness in Gingivitis Patients: A Randomized Clinical Trial
The aim of this study is to comparatively evaluate the effectiveness of two different oral hygiene instruction methods given in addition to Phase 1 periodontal treatment in patients diagnosed with gingivitis, on periodontal clinical parameters and patient awareness scores, and to examine the relationship between the change in awareness score and clinical improvement. The main question it aims to answer is:
Is video-based visual oral hygiene training as memorable and motivating as hands-on training using a model?
A total of 80 patients who were diagnosed with gingivitis were included in the study. The oral health of the patients was assessed by a researcher using periodontal indices, and patients were asked to complete a 10-question questionnaire to assess their own periodontal health and oral hygiene status (T0). Following baseline measurements, all patients received standard Phase 1 periodontal treatment by another clinician. At the end of treatment, patients were randomly assigned to two different oral hygiene instruction (OHI) groups of 40 each:
Group 1 (Video Group): Oral hygiene instruction in this group was provided through standard video content; Group 2 (Model Group): Oral hygiene instruction was given through practical demonstration using three-dimensional dental models.
Patients were called for a follow-up appointment one month after the Phase 1 periodontal treatment (T1). All initial clinical indices were measured and recorded, and patients were asked to complete the same awareness questionnaire again.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The periodontal indices to be evaluated at time points T0 and T1 in the study was determined as follows:
- Plaque index (Löe & Silness) to evaluate the individual oral hygiene performance of the patient. Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
- Gingival index (Sillness & Löe) evaluates the inflammatory response of the gingiva due to plaque accumulation. In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
- Pocket depth measurement on probing to assess the amount of destruction caused by periodontal disease at the base of the gingival groove. It is a measurement that gives a numerical value in millimeters, and as the measured number increases, it indicates greater tissue destruction caused by periodontal disease and a deeper periodontal pocket.
- Bleeding on probing is used to determine whether periodontal disease is in an active destructive phase at the base of the gingival groove. The bleeding on probing index is used to detect and record bleeding that may occur upon contact of the probe with the base of the periodontal pocket, and is scored as "present" or "absent".
The numerical value recorded as the awareness score is obtained from the patients' answers to 10 questions in the survey. Each question is answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum. As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
Periodontal measurements and patient awareness questionnaire scores from both time points were recorded, and pairwise comparisons, analysis of covariance, and correlation analyses were conducted to analyze the observed change and evaluate the response of the two groups to treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06560
- Ankara University Faculty of Denstistry Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having an average whole-mouth gingival index (GI) score above 2.0
Exclusion Criteria:
Individuals with an average gingival index below 2.0,
- Individuals with periodontal pockets deeper than 4 mm in one or more areas,
- Individuals with fixed prosthetic restorations in any tooth,
- Individuals who have received periodontal treatment within the last 6 months,
- Individuals who smoke or use similar tobacco products,
- Individuals who have used antibiotics for any reason within the last 3 months,
- Individuals who are unable to perform adequate oral hygiene practices,
- Individuals who have lost 5 or more teeth other than wisdom teeth,
- Individuals under 18 or over 65 years of age were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: video group
Phase 1 periodontal therapy + Video-based oral hygiene instruction
|
Following standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received standardized oral hygiene instruction via a video presentation.
The video demonstrated proper tooth brushing and interdental cleaning techniques.
A link to the video was also provided to the patients for at-home reinforcement.
|
|
Experimental: model group
Phase 1 periodontal therapy + model-based oral hygiene instruction
|
Following standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received practical oral hygiene instruction demonstrated on a 3D dental model by the researcher.
The demonstration included proper tooth brushing and interdental cleaning techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plaque index
Time Frame: Baseline (T0) and 1 month (T1)
|
Plaque index (Silness & Löe) to evaluate the individual oral hygiene performance of the patient.
Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
|
Baseline (T0) and 1 month (T1)
|
|
Change in gingival index
Time Frame: Baseline (T0) and 1 month (T1)
|
Gingival index (Löe&Silness) evaluates the inflammatory response of the gingiva due to plaque accumulation.
In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
|
Baseline (T0) and 1 month (T1)
|
|
Change in awareness score
Time Frame: Baseline (T0) and 1 Month (T1)
|
The numerical value recorded as the awareness score was obtained from the patients' answers to 10 questions in the survey.
Each question was answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum.
As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
|
Baseline (T0) and 1 Month (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in probing depth
Time Frame: Baseline (T0) and 1 Month (T1)
|
Pocket depth measurement on probing to assess the amount of destruction caused by periodontal disease at the base of the gingival groove.
It is a measurement that gives a numerical value in millimeters, and as the measured number increases, it indicates greater tissue destruction caused by periodontal disease and a deeper periodontal pocket.
|
Baseline (T0) and 1 Month (T1)
|
|
Change in bleeding on probing
Time Frame: Baseline (T0) and 1 Month (T1)
|
Bleeding on probing is used to determine whether periodontal disease is in an active destructive phase at the base of the gingival groove.
The bleeding on probing index is used to detect and record bleeding that may occur upon contact of the probe with the base of the periodontal pocket, and is scored as "present" or "absent".
|
Baseline (T0) and 1 Month (T1)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- A. Demirel, H. S. Güçlü, M. Güçlü, and N. Bağış, "Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial," International Journal of Dental Hygiene 23, no. 3, (2025): 575-583.
- A. Lees, and W. P. Rock, "A comparison between written, verbal, and videotape oral hygiene instruction for patients with fixed appliances," Journal of Orthodontics 27, no. 4 (2000): 323-328.
- P. L. Lee, S. A. Othman, N. A. A. Fauzi, and M. Z. Hussin, "Effectiveness of Video-Based Oral Hygiene Education Reinforcement During Fixed Orthodontic Treatment in Adults: A Randomised Clinical Trial," International Journal of Dental Hygiene, (2025): 1-11
- N. Almotairy, A. A. Aleid, and A. S. Almutairi, "Effect of consequence-based visual education on oral hygiene outcomes: Randomized controlled clinical trial," Journal of the American Dental Association (2026): S0002-8177(25)00683-X.
- M. Ghaffari, S. Rakhshanderou, A. Ramezankhani, M. Noroozi, and B. Armoon, "Oral health education and promotion programmes: meta-analysis of 17-year intervention," International Journal of Dental Hygiene 16, no. 1 (2018): 59-67.
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
- 2024-08/17
- 1919B012324619 (Other Identifier: TÜBİTAK Directorate of Scientist Support Programs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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