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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Motivational Interviewing; Computer-Aided Design
• Intervention / Treatment: Procedure: scaling root planing; Behavioral: Three-Dimensional Animation (video1-2); Behavioral: Three-Dimensional Animation (video 3); Behavioral: Periodontal Disease Prediction (PDP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34000
      • Bezmialem Vakıf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Method (CM); 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; 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.
Active Comparator: Three-Dimensional Animation (3DA); 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; 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.; Behavioral: Three-Dimensional Animation (video1-2); 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); Behavioral: Three-Dimensional Animation (video 3); 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.
Experimental: Periodontal Disease Prediction (PDP); 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; 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.; Behavioral: Three-Dimensional Animation (video1-2); 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); Behavioral: Periodontal Disease Prediction (PDP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth (PD)	PD measurements was evaluated at six regions of each tooth	baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
bleeding on probing (BoP)	BoP associated with PD measurements was evaluated at six regions of each tooth as presence/absence and recorded as %.	baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
papillary bleeding index (PBI)	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.	baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Gingival ındex (GI)	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.	baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: The Scientific and Technological Research Council of Turkey; Abant Izzet Baysal University
• Investigators: Study Director: Sadiye Gunpinar, Asc. Prof., Bezmialem Vakif University

Publications and helpful links

General Publications

• Gunpinar S, Sevinc AS, Akgul Z, Tasmektepligilc AA, Gunpinar E. Patient-Specific Gingival Recession System Based on Periodontal Disease Prediction. Int J Comput Dent. 2023 Dec 19;0(0):0. doi: 10.3290/j.ijcd.b4784721. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: periodontal disease; motivational interview; computer-aided design; Oral hygiene motivation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: SGUNPINAR/119S025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No