Periodontal DiseasesNCT05809570
Periodontal Disease Prediction System
An observational study of Periodontal Diseases, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Clinical examination
- How many people
- 1,057 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology for their rutin periodontal controls or complains about gingival problems were included in this study.
Who may be able to join
- Age greater than 18 years,
- Periodontal status ranging from no clinical periodontal disease (<10% with bleeding on probing) to periodontitis (stage I to IV)
- Patients having at least one teeth in each quadrant were included.
Who cannot join
- Patients undergoing orthodontic treatment and using anti-inflammatory drugs were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Disease Prediction System and a Patient-Specific Gingival Recession Simulator
The purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems.
Read the detailed description
Periodontal Disease Prediction (PDP) software has three components: a) Data Loading Window (DLW) b) Three-Dimensional Mouth Model (3DM) and c) Periodontal Attachment Loss Indicator (PLI). Demographic and clinical examinations of 1057 volunteers were recorded to DLW. An unsupervised machine learning K means clustering analysis was used to categorize the data obtained from the study population and identified the periodontal risk groups. An intraoral scanner was utilized to capture direct optical intraoral data of a patient and transferred to the 3DM. The intraoral model went under two algorithm steps for obtaining a recessed model. First, gingival curves separating gingiva and tooth were extracted using a Dijkstra's algorithm. Limit curves determining boundaries of recessed regions in the intraoral model were then obtained using gingival curves. The gingival recession was then mimicked by losing gingiva and disappearing tooth roots at proper locations in the intraoral model and Additionally, the final four different 3 dimensional recessed model (maxilla, mandibula, anterior teeth and posterior teeth) belonging to the same patient were scored based on the similarity to the real gingival recession by 25 periodontology specialist via online survey.
- Conditions
- Periodontal Diseases
- Being tested
- Clinical examination
- Keywords
- gingival recession, Oral hygiene motivation, Computer-aided design
- Medical subject headings
- Periodontal Diseases, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationDiagnostic test
A total of 1057 individuals who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology and agreed to participate in the study were clinically and radiologically examined.
An intraoral scanner was utilized to capture direct optical intraoral data of a patient.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal examination | Cross- sectional clinical periodontal examinations and measurements were performed using a Williams periodontal probe Receives: Diagnostic Test: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sites Clinical Attachment Loss≥5 mm
Categorized as: None, <4, 4-8, >8
Measured: Baseline
Secondary outcomes (17)
Presence of diabetes
Categorized as: Absence, diabetes with HbA1c<7, diabetes with HbA1c≥7
Measured: Baseline
Smoking status
Categorized as: None, < 10 per day, ≥10 per day
Measured: Baseline
Patient cooperation and awareness
Categorized as: None, some, high
Measured: Baseline
History of dental treatment
Categorized as: None, treated in the last 1 year
Measured: Baseline
Tooth brushing Habits
Categorized as: None/ 1 time in day/ ≥2 times in day
Measured: Baseline
Interproximal cleaning
Categorized as: None/ 1 time in day/ ≥2 times in day
Measured: Baseline
Alveolar bone loss/age
Categorized as: None/ <0.25 /0.25-1/ >1
Measured: Baseline
Number of sites Probing Pocket Depth ≥5 mm
Categorized as: None/ <4 / 4-8/ >8
Measured: Baseline
Number of sites Bleeding on Probing (%)
Categorized as: <10%/ 10-25%/ >25%
Measured: Baseline
Tooth mobility
Categorized as: None/ Miller I/ Miller II/ Miller III
Measured: Baseline
Gingival phenotype
Categorized as: Thin/thick
Measured: Baseline
Presence of furcation involvement
Categorized as: None/ horizontal involvement/ vertical involvement/ combined
Measured: Baseline
Vertical alveolar bone loss
Categorized as: Presence/absence
Measured: Baseline
Presence of endodontic tooth problem
Categorized as: Presence/absence
Measured: Baseline
Number of tooth loss
Categorized as: None/ <4/ 4-8/ >8
Measured: Baseline
Traumatic occlusion
Categorized as: Presence/absence
Measured: Baseline
Restorations including gingival margin
Categorized as: Presence/absence
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jun 2020
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University, Istanbul Technical University, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Şadiye GÜNPINAR, Bezmialem Vakif University
- Investigators
- Şadiye Günpınar, Assoc. Prof, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809570
- Sponsor's protocol ID
- 119S025
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared if the researchers contact to the principal investigator after 6 months following the publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease Prediction System and a Patient-Specific Gingival Recession Simulator
- ClinicalTrials.gov ID
- NCT05809570
- Acronym / sponsor ID
- 119S025
- Conditions
- Periodontal Diseases
- Keywords
- gingival recession, Oral hygiene motivation, Computer-aided design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University, Istanbul Technical University, The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 12 Apr 2023 (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 purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems.
Detailed description
Periodontal Disease Prediction (PDP) software has three components: a) Data Loading Window (DLW) b) Three-Dimensional Mouth Model (3DM) and c) Periodontal Attachment Loss Indicator (PLI). Demographic and clinical examinations of 1057 volunteers were recorded to DLW. An unsupervised machine learning K means clustering analysis was used to categorize the data obtained from the study population and identified the periodontal risk groups. An intraoral scanner was utilized to capture direct optical intraoral data of a patient and transferred to the 3DM. The intraoral model went under two algorithm steps for obtaining a recessed model. First, gingival curves separating gingiva and tooth were extracted using a Dijkstra's algorithm. Limit curves determining boundaries of recessed regions in the intraoral model were then obtained using gingival curves. The gingival recession was then mimicked by losing gingiva and disappearing tooth roots at proper locations in the intraoral model and Additionally, the final four different 3 dimensional recessed model (maxilla, mandibula, anterior teeth and posterior teeth) belonging to the same patient were scored based on the similarity to the real gingival recession by 25 periodontology specialist via online survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontal examination | – | Diagnostic Test: Clinical examinationCross- sectional clinical periodontal examinations and measurements were performed using a Williams periodontal probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology for their rutin periodontal controls or complains about gingival problems were included in this study.
Key inclusion criteria (3 listed)
- Age greater than 18 years,
- Periodontal status ranging from no clinical periodontal disease (<10% with bleeding on probing) to periodontitis (stage I to IV)
- Patients having at least one teeth in each quadrant were included.
Key exclusion criteria (1 listed)
- Patients undergoing orthodontic treatment and using anti-inflammatory drugs were excluded.
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 |
|---|---|---|
| Clinical examinationA total of 1057 individuals who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology and agreed to participate in the study were clinically and radiologically examined. An intraoral scanner was utilized to capture direct optical intraoral data of a patient. | Diagnostic test | Periodontal examination |
Primary outcome
Number of sites Clinical Attachment Loss≥5 mm
Time frame: Baseline
Categorized as: None, <4, 4-8, >8
17 secondary outcomes
Presence of diabetes
Time frame: Baseline
Smoking status
Time frame: Baseline
Patient cooperation and awareness
Time frame: Baseline
History of dental treatment
Time frame: Baseline
Tooth brushing Habits
Time frame: Baseline
Interproximal cleaning
Time frame: Baseline
Alveolar bone loss/age
Time frame: Baseline
Number of sites Probing Pocket Depth ≥5 mm
Time frame: Baseline
Number of sites Bleeding on Probing (%)
Time frame: Baseline
Tooth mobility
Time frame: Baseline
Gingival phenotype
Time frame: Baseline
Presence of furcation involvement
Time frame: Baseline
Vertical alveolar bone loss
Time frame: Baseline
Presence of endodontic tooth problem
Time frame: Baseline
Number of tooth loss
Time frame: Baseline
Traumatic occlusion
Time frame: Baseline
Restorations including gingival margin
Time frame: Baseline
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 14 Apr 2023.
- Individual participant dataSharing planned: Undecided. Data will be shared if the researchers contact to the principal investigator after 6 months following the publication
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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.
Şadiye Günpınar, Assoc. Prof principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, 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 3 inclusion and 1 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 14 Apr 2023. 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?
Number of sites Clinical Attachment Loss≥5 mm (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2023.