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

NCT ID: NCT06577246

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-07-24

Brief Summary

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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

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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.

Conditions

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Motivational Interviewing Computer-Aided Design Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

scaling root planing

Intervention Type 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 (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.

Group Type ACTIVE_COMPARATOR

scaling root planing

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

scaling root planing

Intervention Type 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)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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)

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Şadiye GÜNPINAR

principal ınvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sadiye Gunpinar, Asc. Prof.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

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Bezmialem Vakıf University

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 38112604 (View on PubMed)

Other Identifiers

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SGUNPINAR/119S025

Identifier Type: -

Identifier Source: org_study_id

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