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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06071338
Other study ID # H-06-B-091
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 30, 2024

Study information

Verified date October 2023
Source Ministry of Health, Saudi Arabia
Contact Abdulrahman Al Shehri, BSD, MS
Phone +966507090251
Email alshehriabdulrahman3@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Clinical Periodontal Examination
No details will be published from the clinical assessment.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Saudi Arabia

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

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