Motivational InterviewingNCT06577246
Assessment of the Effect of Periodontal Disease Prediction System on Oral Hygiene Motivation
A study testing scaling root planing, Three-Dimensional Animation (video1-2) and Three-Dimensional Animation (video 3) in people with Motivational Interviewing and Computer-Aided Design, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, Computer-Aided Design, Periodontal Diseases
- What is being tested?
- scaling root planing, Three-Dimensional Animation (video1-2) and Three-Dimensional Animation (video 3)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Presence of diffuse dentinal hypersensitivity.
- Acute infections.
- Faulty restorations.
- Root caries complicating oral hygiene.
- Full-mouth fixed or removable dentures.
- Ongoing orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Fatih, 34000
About this study
Official title: 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.
Read the 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.
- Being tested
- scaling root planing, Three-Dimensional Animation (video1-2), Three-Dimensional Animation (video 3), Periodontal Disease Prediction (PDP)
- Keywords
- Oral hygiene motivation, computer-aided design, periodontal disease, motivational interview
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling root planingProcedure or surgery
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)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: scaling root planing; Behavioral: Three-Dimensional Animation (video1-2); Behavioral: Periodontal Disease Prediction (PDP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Secondary outcomes (4)
Probing depth (PD)
PD measurements was evaluated at six regions of each tooth
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jun 2021
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Şadiye GÜNPINAR, Bezmialem Vakif University
- Investigators
- Sadiye Gunpinar, Asc. Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577246
- Sponsor's protocol ID
- SGUNPINAR/119S025
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38112604
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Disease Prediction System on Oral Hygiene Motivation in Patients With Periodontitis: A Prospective Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06577246
- Acronym / sponsor ID
- SGUNPINAR/119S025
- Keywords
- Oral hygiene motivation, computer-aided design, periodontal disease, motivational interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University, The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Method (CM) | Active comparator | Procedure: scaling root planingIndividuals 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. |
| Three-Dimensional Animation (3DA) | Active comparator | Procedure: scaling root planing, Behavioral: Three-Dimensional Animation (video1-2), Behavioral: Three-Dimensional Animation (video 3)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. |
| Periodontal Disease Prediction (PDP) | Experimental | Procedure: scaling root planing, Behavioral: Three-Dimensional Animation (video1-2), 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 (1). These projections were presented to the patients in three dimensions with PDP visualisation. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- Presence of diffuse dentinal hypersensitivity.
- Acute infections.
- Faulty restorations.
- Root caries complicating oral hygiene.
- Full-mouth fixed or removable dentures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scaling root planingperiodontal 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. | Procedure or surgery | Conventional Method (CM), Periodontal Disease Prediction (PDP), Three-Dimensional Animation (3DA) |
| 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) | Behavioural | Periodontal Disease Prediction (PDP), Three-Dimensional Animation (3DA) |
| 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. | Behavioural | Three-Dimensional Animation (3DA) |
| 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. | Behavioural | Periodontal Disease Prediction (PDP) |
Primary outcome
rustogi modified navy plaque index (RMNPI)
Time frame: 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)
4 secondary outcomes
Probing depth (PD)
Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
bleeding on probing (BoP)
Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
papillary bleeding index (PBI)
Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Gingival ındex (GI)
Time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Background: PubMed 38112604Gunpinar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadiye Gunpinar, Asc. Prof. study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling root planing, Three-Dimensional Animation (video1-2) and Three-Dimensional Animation (video 3) in people with Motivational Interviewing and Computer-Aided Design, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rustogi modified navy plaque index (RMNPI) (time frame: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.