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WithdrawnNCT07479706Updated Sep 10, 2026

Impact of Oral Hygiene Instruction in Gingivitis Patients

An interventional study of video-based oral hygiene instruction and Model-based oral hygiene instruction in Plaque-Induced Gingivitis, sponsored by Ankara University. Withdrawn at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Ankara University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
The study record is withdrawn due to administrative errors in the questionnaire methodology section. A new, corrected protocol will be registered.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jun 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Plaque-Induced Gingivitis

Keywords

  • Gingivitis
  • Dental plaque
  • Oral hygiene instruction
  • Disease awareness
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

Browse Gingivitis studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Having an average whole-mouth gingival index (GI) score above 2.0

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    video group

    Phase 1 periodontal therapy + Video-based oral hygiene instruction

    Behavioral: video-based oral hygiene instruction

  • Experimental
    model group

    Phase 1 periodontal therapy + model-based oral hygiene instruction

    Behavioral: Model-based oral hygiene instruction

Interventions

  • Behavioralvideo-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.

  • BehavioralModel-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.

06

What researchers measure

Primary outcomes

  1. Change in plaque index

    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.

    Time frame: Baseline (T0) and 1 month (T1)

  2. Change in gingival index

    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.

    Time frame: Baseline (T0) and 1 month (T1)

  3. Change in awareness score

    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.

    Time frame: Baseline (T0) and 1 Month (T1)

Secondary outcomes

  1. Change in probing depth

    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.

    Time frame: Baseline (T0) and 1 Month (T1)

  2. Change in bleeding on probing

    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".

    Time frame: Baseline (T0) and 1 Month (T1)

07

Study locations

1 site
  • Ankara University Faculty of Denstistry Department of Periodontology
    Ankara, 06560, Turkey (Türkiye)
08

References and documents

Publications

  • Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29. PubMed 39887898 ↗
  • Lees A, Rock WP. A comparison between written, verbal, and videotape oral hygiene instruction for patients with fixed appliances. J Orthod. 2000 Dec;27(4):323-8. doi: 10.1093/ortho/27.4.323. PubMed 11099571 ↗
  • Lee PL, Othman SA, Fauzi NAA, Hussin MZ. Effectiveness of Video-Based Oral Hygiene Education Reinforcement During Fixed Orthodontic Treatment in Adults: A Randomised Clinical Trial. Int J Dent Hyg. 2026 May;24(2):226-236. doi: 10.1111/idh.70008. Epub 2025 Nov 23. PubMed 41276919 ↗
  • Almotairy N, Aleid AA, Almutairi AS. Effect of consequence-based visual education on oral hygiene outcomes: Randomized controlled clinical trial. J Am Dent Assoc. 2026 Jun;157(6):619-628.e2. doi: 10.1016/j.adaj.2025.11.006. Epub 2026 Jan 9. PubMed 41511431 ↗
  • Ghaffari M, Rakhshanderou S, Ramezankhani A, Noroozi M, Armoon B. Oral Health Education and Promotion Programmes: Meta-Analysis of 17-Year Intervention. Int J Dent Hyg. 2018 Feb;16(1):59-67. doi: 10.1111/idh.12304. Epub 2017 Aug 24. PubMed 28836347 ↗

Individual participant data

Plan to share: Yes — All IPD collected throughout the trial will be shared

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479706
Lead sponsor
Ankara University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
İlkim Karadağ (Principal investigator, Ankara University) — Principal investigator
First posted
Mar 18, 2026
Start date
Jun 1, 2024
Primary completion
Jul 31, 2024
Completion
Feb 1, 2025
Last update
Sep 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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