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

Not Applicable

Completed

• Conditions: Computer-Aided Design; Periodontal Diseases; Motivational Interviewing

• Registration Number: NCT06577246
• Lead Sponsor: Bezmialem Vakif University

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.

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 Timeline

• Study Start: 2021-06-01
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
rustogi modified navy plaque index (RMNPI)	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 Outcome Measures

Name	Time	Method
papillary bleeding index (PBI)	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.
Probing depth (PD)	baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months	PD measurements was evaluated at six regions of each tooth
bleeding on probing (BoP)	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 %.
Gingival ındex (GI)	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.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Fatih, Turkey