A Decision Support System Based on Classification Algorithms for the Diagnosis of Periodontal Disease

Sponsor

Ministry of Health, Saudi Arabia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06071338

Collaborator

(none)

250

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases	Diagnostic Test: Clinical Periodontal Examination

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

A Decision Support System Based on Classification Algorithms for the Diagnosis of Periodontal Disease

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Outcome Measures

Primary Outcome Measures

Age [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
Gender [One time measure; baseline during periodontal clinical examination.]
Male; Female.
Marital statue [One time measure; baseline during periodontal clinical examination.]
Married, widowed, divorced, never married
Education [One time measure; baseline during periodontal clinical examination.]
< secondary school, secondary school, graduate or equivalent, some college or associates degree, College graduate or higher
Physical Activities [One time measure; baseline during periodontal clinical examination.]
Light, Moderate, Heavy
Bleeding on Probing [One time measure; baseline during periodontal clinical examination.]
Yes; No
Gingival Index [One time measure; baseline during periodontal clinical examination.]
Percentage
Plaque Index [One time measure; baseline during periodontal clinical examination.]
Percentage
Periodontal Probing Depth [One time measure; baseline during periodontal clinical examination.]
PPD at the site of greatest loss (number)
Recession Type [One time measure; baseline during periodontal clinical examination.]
Yes; No
Clinical Attachment Loss [One time measure; baseline during periodontal clinical examination.]
CAL at the site of greatest loss (number)
Radiographic Bone Loss [One time measure; baseline during periodontal clinical examination.]
RBL at the site of greatest loss (percentage)
Tooth Mobility [One time measure; baseline during periodontal clinical examination.]
Yes; No
Missing Teeth [One time measure; baseline during periodontal clinical examination.]
Yes; No
Furcation Involvement [One time measure; baseline during periodontal clinical examination.]
Yes; No
Diabetes [One time measure; baseline during periodontal clinical examination.]
Healthy, <7% HbA1c, ≥7% HbA1c
Smoking [One time measure; baseline during periodontal clinical examination.]
None, <10 cig/day, ≥10cig/day
Body Mass Index [One time measure; baseline during periodontal clinical examination.]
Underweight, Healthy, Overweight, Obese
Cardiovascular Disease [One time measure; baseline during periodontal clinical examination.]
Yes; No

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ministry of Health, Saudi Arabia

Investigators

Principal Investigator: Abdulrahman Al Shehri, BDS, MS, General Directorate of Health Affairs, Aseer Region, KSA.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdulrahman Alshehri, Principal Investigator/Clinical Specialist, Ministry of Health, Saudi Arabia

ClinicalTrials.gov Identifier:

NCT06071338

Other Study ID Numbers:

H-06-B-091

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abdulrahman Alshehri, Principal Investigator/Clinical Specialist, Ministry of Health, Saudi Arabia

Additional relevant MeSH terms:

Periodontal Diseases

Study Results

No Results Posted as of Oct 6, 2023