NCT07479706

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 10, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

GingivitisDental plaqueOral hygiene instructionDisease awareness

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline (T0) and 1 month (T1)

  • 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.

    Baseline (T0) and 1 month (T1)

  • 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.

    Baseline (T0) and 1 Month (T1)

Secondary Outcomes (2)

  • Change in probing depth

    Baseline (T0) and 1 Month (T1)

  • Change in bleeding on probing

    Baseline (T0) and 1 Month (T1)

Study Arms (2)

video group

EXPERIMENTAL

Phase 1 periodontal therapy + Video-based oral hygiene instruction

Behavioral: video-based oral hygiene instruction

model group

EXPERIMENTAL

Phase 1 periodontal therapy + model-based oral hygiene instruction

Behavioral: Model-based oral hygiene instruction

Interventions

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.

video group

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.

model group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Denstistry Department of Periodontology

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
While the researcher measuring periodontal parameters was not masked, the researcher administering the treatments and analyzing the data was masked.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 18, 2026

Study Start

June 1, 2024

Primary Completion

July 31, 2024

Study Completion

February 1, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations