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Completed

NCT Number: NCT06577246

Assessment of the Effect of Periodontal Disease Prediction System on Oral Hygiene Motivation

The aim of this trial is to evaluate the effect of patient specific periodontal disease prediction (PDP) system, a part of motivational interview, (MI) on probing depth (PD), Rustogi modified Navy Plaque Index (RMNPI), and papillary bleeding index (PBI) scores in patients with periodontitis following non-surgical periodontal therapy.

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Key information

Conditions

Motivational Interviewing Computer-Aided Design Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, Fatih, 34000, Turkey (Türkiye)

About this study

A total of 120 participants included in our study and were then randomly assigned to three groups: a) conventional method (CM) (n=40), b) three-dimensional animation (3DA) (n=40), and c) Periodontal Disease Prediction (PDP) interaction (n=40). PD, PBI, and RMNPI values were recorded before periodontal therapy (T0). Following periodontal treatment, individuals in the CM group were instructed on oral hygiene via a model and brochure. Individuals in the 3DA group were informed using 3D video visuals. Participants in the PDP group were informed in a computer-based three-dimensional manner, providing projections of their current status and potential future gingival recessions after viewing the first and second parts of the 3D animation. Clinical periodontal measurements were repeated at 3, 6, and 12 months post-treatment. Data obtained after the study were analyzed using appropriate statistical methods. It was concluded that the proposed approach in this project could enhance periodontitis individuals' awareness about periodontal disease and personal oral hygiene especially for interdental cleaning over a long period. By this way, this PDP system can lead clinical benefits in reducing the recurrence of periodontal disease. It was hypothesized that patients in the PDP group could achieve significantly better plaque control and have lower bleeding scores compared to patients in the control groups, which include traditional oral hygiene motivation and three-dimensional video education.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 30 to 60 years.
  • No prior periodontal treatment or oral hygiene education.
  • Simplified Oral Hygiene Index (OHI-S) greater than 3 (indicating poor oral hygiene).
  • Diagnosed with 'Stage III' 'Grade B' periodontitis.
  • At least 20 natural teeth present (excluding third molars).
  • Minimum of 12 years of education.
  • Not a dentist or dental student.
  • No systemic diseases affecting memory or cognitive function.
  • No physical disabilities that could hinder the performance of oral hygiene procedures.

Exclusion criteria

  • Presence of diffuse dentinal hypersensitivity.
  • Acute infections.
  • Faulty restorations.
  • Root caries complicating oral hygiene.
  • Full-mouth fixed or removable dentures.
  • Ongoing orthodontic treatment.

Treatment and study plan

Scaling root planing

Procedure

periodontal treatment in all groups was performed using ultrasonic and hand instruments (#15/30, #6/7) by the same physician (UGE) who was blind to the study groups.

Three-Dimensional Animation (video1-2)

Behavioral

The video used in the study was created by DentalMaster (MD Stimulation Ltd) by combining their own footage (http://www.mdsimulation.com/). This video is divided into three parts, summarized below:

  • i. Overview of the causes and symptoms of periodontal disease (section 1)
  • ii. Treatment of periodontal disease and daily oral care practices for individuals (section 2)

Three-Dimensional Animation (video 3)

Behavioral

iii.Consequences of periodontal disease (such as gingival recession and tooth loss) that individuals may face if periodontal diseases are not treated and if they do not perform regular oral care (section 3). In this group, patients watch the video together with the physician (SG), who is familiar with the randomized patient groups.

Periodontal Disease Prediction (PDP)

Behavioral

The patients in the test group viewed sections 1 and 2 videos in the same manner as the 3DA group. However, unlike the 3DA group, they did not view section 3. Instead, they were shown estimates of their current condition and potential future periodontal tissue loss (gingival recession) for 1-5 years, 5-10 years, and 10-20 years. These projections were presented to the patients in three dimensions with PDP visualisation.

Primary outcomes

  1. rustogi modified navy plaque index (RMNPI)

    Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

    RMNPI was assessed using a specialized plaque staining agent on each of the nine sites on both buccal and lingual tooth surfaces. The individual mean PI was calculated by scoring the presence of plaque at each site as '1' and its absence as '0', then dividing by the total number of surfaces evaluated. Using this index, PI can be separately calculated for the entire mouth (A-I), the gingival margin (A-C), interproximal areas (D and F), and surfaces that come into contact with dental floss (A, C, D, and F)

Secondary outcomes

  1. Probing depth (PD)

    Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

    PD measurements was evaluated at six regions of each tooth

  2. bleeding on probing (BoP)

    Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

    BoP associated with PD measurements was evaluated at six regions of each tooth as presence/absence and recorded as %.

  3. papillary bleeding index (PBI)

    Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

    PBI is calculated by scoring the papillae in the facial/buccal and palatinal/lingual regions of each tooth based on the presence or absence of bleeding from probing and the overall condition of the gingiva. The average PBI value for an individual was calculated by dividing the total sum of the values by the number of papillae assessed.

  4. Gingival ındex (GI)

    Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

    Each tooth's mesial, distal, buccal, and lingual gingival margins are evaluated. These values are then summed and divided by four. This process calculates the Gingival Index (GI) for each tooth. When the total of these values is divided by the number of teeth, the individual's GI score is obtained.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Abant Izzet Baysal University
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effects of Periodontal Disease Prediction System on Oral Hygiene Motivation in Patients With Periodontitis: A Prospective Randomised Controlled Clinical Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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