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

NCT07706049 | Completed

• 1 other identifier: 2024-08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis and Periodontal Diseases; Gingivitis

Keywords

Gingivitis; oral hyigene instructions; oral health realted self efficiacy

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline (T0) and 1-Month Follow-up (T1)

• 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.

  Baseline (T0) and 1-Month Follow-up (T1)

• 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.

  Baseline (T0) and 1-Month Follow-up (T1)

Secondary Outcomes (2)

• Change in Patient-Reported Subjective Gingival Health (VAS)

  Baseline (T0) and 1-Month Follow-up (T1)

• Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score

  Baseline (T0)

Study Arms (2)

Video-Based Instruction

EXPERIMENTAL

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.

Behavioral: Video-Based Oral Hygiene Instruction

Model-based Instruction

ACTIVE COMPARATOR

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.

Behavioral: Model-Based Oral Hygiene Instruction

Interventions

Video-Based Oral Hygiene Instruction BEHAVIORAL

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.

Video-Based Instruction

Model-Based Oral Hygiene Instruction BEHAVIORAL

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.

Model-based Instruction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 25472523 BACKGROUND

• 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.

  PMID: 10487313 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the educational and interactive nature of the interventions (watching a video vs. receiving hands-on model demonstration), it is not possible to blind the patients or the care provider (the clinician delivering the instruction). Therefore, masking is strictly limited to the Outcomes Assessor (the clinical examiner), who performs all baseline (T0) and follow-up (T1) periodontal measurements and remains completely unaware of the patients' group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Researcher

Model Details: 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 and at a 1-month follow-up.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: February 1, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months and ending 36 months following the publication of the article.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for the purpose of achieving the specific aims outlined in their approved proposal. Requests should be directed to the corresponding author via email.

Locations

TU (1)