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

NCT06577246 | Completed

• 1 other identifier: SGUNPINAR/119S025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motivational Interviewing; Computer-Aided Design; Periodontal Diseases

Keywords

Oral hygiene motivation; computer-aided design; periodontal disease; motivational interview

Outcome Measures

Primary Outcomes (1)

• rustogi modified navy plaque index (RMNPI)

  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)

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

Secondary Outcomes (4)

• Probing depth (PD)

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

• bleeding on probing (BoP)

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

• papillary bleeding index (PBI)

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

• Gingival ındex (GI)

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

Study Arms (3)

Conventional Method (CM)

ACTIVE COMPARATOR

Individuals in this group receive instructions on oral care after initial periodontal treatment from the physician (SG) who is familiar with the patient groups. The physician verbally explains the development of periodontal disease, its causes, symptoms, and the potential consequences of irregular oral care, using a brochure to reinforce these points.

Procedure: scaling root planing

Three-Dimensional Animation (3DA)

ACTIVE COMPARATOR

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) * 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.

Procedure: scaling root planing; Behavioral: Three-Dimensional Animation (video1-2); Behavioral: Three-Dimensional Animation (video 3)

Periodontal Disease Prediction (PDP)

EXPERIMENTAL

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 (1). These projections were presented to the patients in three dimensions with PDP visualisation.

Procedure: scaling root planing; Behavioral: Three-Dimensional Animation (video1-2); Behavioral: Periodontal Disease Prediction (PDP)

Interventions

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.

Conventional Method (CM); Periodontal Disease Prediction (PDP); Three-Dimensional Animation (3DA)

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)

Periodontal Disease Prediction (PDP); Three-Dimensional Animation (3DA)

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.

Three-Dimensional Animation (3DA)

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.

Periodontal Disease Prediction (PDP)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Abant Izzet Baysal University: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Gunpinar S, Sevinc AS, Akgul Z, Tasmektepligil AA, Gunpinar E. Patient-specific gingival recession system based on periodontal disease prediction. Int J Comput Dent. 2025 Apr 3;28(1):35-45. doi: 10.3290/j.ijcd.b4784721.

  PMID: 38112604 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sadiye Gunpinar, Asc. Prof.

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal ınvestigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: June 1, 2021
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

TU (1)