NCT06071338

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

September 22, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

periodontaldiseasediagnosismachinelearningSaudi

Outcome Measures

Primary Outcomes (19)

  • 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.

  • Gender

    Male; Female.

    One time measure; baseline during periodontal clinical examination.

  • Marital statue

    Married, widowed, divorced, never married

    One time measure; baseline during periodontal clinical examination.

  • 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.

  • Physical Activities

    Light, Moderate, Heavy

    One time measure; baseline during periodontal clinical examination.

  • Bleeding on Probing

    Yes; No

    One time measure; baseline during periodontal clinical examination.

  • Gingival Index

    Percentage

    One time measure; baseline during periodontal clinical examination.

  • Plaque Index

    Percentage

    One time measure; baseline during periodontal clinical examination.

  • Periodontal Probing Depth

    PPD at the site of greatest loss (number)

    One time measure; baseline during periodontal clinical examination.

  • Recession Type

    Yes; No

    One time measure; baseline during periodontal clinical examination.

  • Clinical Attachment Loss

    CAL at the site of greatest loss (number)

    One time measure; baseline during periodontal clinical examination.

  • Radiographic Bone Loss

    RBL at the site of greatest loss (percentage)

    One time measure; baseline during periodontal clinical examination.

  • Tooth Mobility

    Yes; No

    One time measure; baseline during periodontal clinical examination.

  • Missing Teeth

    Yes; No

    One time measure; baseline during periodontal clinical examination.

  • Furcation Involvement

    Yes; No

    One time measure; baseline during periodontal clinical examination.

  • Diabetes

    Healthy, \<7% HbA1c, ≥7% HbA1c

    One time measure; baseline during periodontal clinical examination.

  • Smoking

    None, \<10 cig/day, ≥10cig/day

    One time measure; baseline during periodontal clinical examination.

  • Body Mass Index

    Underweight, Healthy, Overweight, Obese

    One time measure; baseline during periodontal clinical examination.

  • Cardiovascular Disease

    Yes; No

    One time measure; baseline during periodontal clinical examination.

Interventions

No details will be published from the clinical assessment.

Also known as: orthopantomography Assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Data will be collected randomly during the study period planned to end by the end of the year 2023. Data will be collected from participants attending the periodontal department at Abha Specialized Dental Center seeking periodontal treatment.

You may qualify if:

  • age 18 or more
  • no periodontal treatment has been done at least 6 months prior to the enrollment
  • seeking periodontal treatment

You may not qualify if:

  • refuse to volunteer in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Periodontal DiseasesDisease

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdulrahman Al Shehri, BDS, MS

    General Directorate of Health Affairs, Aseer Region, KSA.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman Al Shehri, BSD, MS

CONTACT

Abdulrahman Al Shehri, BDS, MS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/Clinical Specialist

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 6, 2023

Study Start

October 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

No intention and no need to share individual patient data with research community.