- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06071338
A Decision Support System Based on Classification Algorithms for the Diagnosis of Periodontal Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cross-sectional study design will be applied. Two hundred fifty patients will be evaluated by an experienced periodontist and used as input variables. The final diagnosis output will be generated by considering relevant information from the patient's medical history, clinical dental examination, and radiographic exam. Of the sample of 250 patients, 20% of the participants will be assigned randomly to the test group, while the rest will be assigned to the training group before feeding it to the algorithms.
The study purposes For periodontal applications, such as diagnosing gingivitis and periodontal disease, artificial intelligence (AI) models have been developed; however, their accuracy and technological maturity are to be evolved. The applications of such technologies in the field of periodontics are walking baby steps worldwide. The Kingdom of Saudi Arabia is moving fast in technology adoption and implementation in different sectors. However, the healthcare sector, especially clinical-related, needs original research applied to Saudi subjects. The literature in the field of machine learning applications in dentistry is limited. Although AI models for periodontology applications are still being developed, they could serve as potent diagnostic instruments. The current study was planned to add to the current gap in the literature.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdulrahman Al Shehri, BSD, MS
- Phone Number: +966507090251
- Email: alshehriabdulrahman3@gmail.com
Study Contact Backup
- Name: Abdulrahman Al Shehri, BDS, MS
- Phone Number: +966507090251
- Email: alshehriabdulrahman3@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 18 or more
- no periodontal treatment has been done at least 6 months prior to the enrollment
- seeking periodontal treatment
Exclusion Criteria:
- refuse to volunteer in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: One time measure; baseline during periodontal clinical examination.
|
<30, 30-34, 35-39, 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-74, 75-79, >80
|
One time measure; baseline during periodontal clinical examination.
|
|
Gender
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Male; Female.
|
One time measure; baseline during periodontal clinical examination.
|
|
Marital statue
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Married, widowed, divorced, never married
|
One time measure; baseline during periodontal clinical examination.
|
|
Education
Time Frame: One time measure; baseline during periodontal clinical examination.
|
< secondary school, secondary school, graduate or equivalent, some college or associates degree, College graduate or higher
|
One time measure; baseline during periodontal clinical examination.
|
|
Physical Activities
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Light, Moderate, Heavy
|
One time measure; baseline during periodontal clinical examination.
|
|
Bleeding on Probing
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
|
Gingival Index
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Percentage
|
One time measure; baseline during periodontal clinical examination.
|
|
Plaque Index
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Percentage
|
One time measure; baseline during periodontal clinical examination.
|
|
Periodontal Probing Depth
Time Frame: One time measure; baseline during periodontal clinical examination.
|
PPD at the site of greatest loss (number)
|
One time measure; baseline during periodontal clinical examination.
|
|
Recession Type
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
|
Clinical Attachment Loss
Time Frame: One time measure; baseline during periodontal clinical examination.
|
CAL at the site of greatest loss (number)
|
One time measure; baseline during periodontal clinical examination.
|
|
Radiographic Bone Loss
Time Frame: One time measure; baseline during periodontal clinical examination.
|
RBL at the site of greatest loss (percentage)
|
One time measure; baseline during periodontal clinical examination.
|
|
Tooth Mobility
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
|
Missing Teeth
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
|
Furcation Involvement
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
|
Diabetes
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Healthy, <7% HbA1c, ≥7% HbA1c |
One time measure; baseline during periodontal clinical examination.
|
|
Smoking
Time Frame: One time measure; baseline during periodontal clinical examination.
|
None, <10 cig/day, ≥10cig/day
|
One time measure; baseline during periodontal clinical examination.
|
|
Body Mass Index
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Underweight, Healthy, Overweight, Obese
|
One time measure; baseline during periodontal clinical examination.
|
|
Cardiovascular Disease
Time Frame: One time measure; baseline during periodontal clinical examination.
|
Yes; No
|
One time measure; baseline during periodontal clinical examination.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdulrahman Al Shehri, BDS, MS, General Directorate of Health Affairs, Aseer Region, KSA.
Publications and helpful links
General Publications
- Ozden FO, Ozgonenel O, Ozden B, Aydogdu A. Diagnosis of periodontal diseases using different classification algorithms: a preliminary study. Niger J Clin Pract. 2015 May-Jun;18(3):416-21. doi: 10.4103/1119-3077.151785.
- Alqahtani HM, Koroukian SM, Stange K, Schiltz NK, Bissada NF. Identifying Factors Associated with Periodontal Disease Using Machine Learning. J Int Soc Prev Community Dent. 2022 Dec 30;12(6):612-622. doi: 10.4103/jispcd.JISPCD_188_22. eCollection 2022 Nov-Dec.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-06-B-091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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