Clinical trial NCT06577246: Assessment of the Effect of Periodontal Disease Prediction System on Oral Hygiene Motivation
Official title: Effects of Periodontal Disease Prediction System on Oral Hygiene Motivation in Patients With Periodontitis: A Prospective Randomised Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Computer-Aided Design
Periodontal Diseases
Keywords: Oral hygiene motivation
computer-aided design
periodontal disease
motivational interview
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Abant Izzet Baysal University
name: The Scientific and Technological Research Council of Turkey
First posted: 2024-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rustogi modified navy plaque index (RMNPI)
timeFrame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Secondary outcomes:
measure: Probing depth (PD)
timeFrame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
measure: bleeding on probing (BoP)
timeFrame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
measure: papillary bleeding index (PBI)
timeFrame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
measure: Gingival ındex (GI)
timeFrame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Sadiye Gunpinar, Asc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.