Periodontal DiseasesNCT07410351
Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning
An observational study of Periodontal Diseases and Periodontitis, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
Trial summary
This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. 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, Periodontitis, Gingivitis
- What is being tested?
- Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)
- How many people
- 393 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Feb 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants will be selected from members of the general public who are scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and study procedures will take place at the center during the scheduled screening visit.
Who may be able to join
- Adult aged 18 years or older
- Able to read and understand the study information and provide informed consent
- Able to complete the online questionnaire independently (on a smartphone/tablet/computer)
- Willing to undergo a same-visit clinical periodontal examination
- Has natural teeth present (dentate)
Who cannot join
- Completely edentulous (no natural teeth)
- Currently undergoing active periodontal treatment (e.g., scaling and root planing) or received periodontal therapy within the past [6 months]
- Took systemic antibiotics within the past [3 months]
- Unable to complete the questionnaire or examination due to cognitive impairment, severe illness, or communication barriers that prevent informed consent
- Refuses or is unable to tolerate the periodontal clinical examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Abha Specialized Dental Center
Abhā, 'Asir Region
Abdulrahman Alshehri, BDS, MS, 00966507090251, alshehriabdulrahman3@gmail.com
About this study
Official title: Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning
This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.
Read the detailed description
Periodontal disease is a common oral health problem that can progress silently and may lead to gum inflammation, tooth loss, and reduced quality of life if not detected and managed early. Many people may not recognize early signs or may delay seeking dental care until symptoms become more noticeable. An online self-assessment tool may help members of the public identify whether they are at higher risk and encourage timely evaluation and preventive care.
This observational study will collect labeled data to evaluate the accuracy of an online periodontal self-assessment tool in the general adult population. Participants will complete a structured online questionnaire that asks about oral and periodontal health symptoms, dental history, oral hygiene practices, and other health-related factors commonly linked to periodontal risk. During the same visit, each participant will undergo a standardized clinical periodontal examination conducted by a trained clinician. The clinical examination will serve as the reference standard to assign a periodontal risk label for each participant, categorized as low, medium, or high risk according to predefined criteria in the study protocol.
The primary purpose of this labeled-data phase is to compare the questionnaire-based assessment with the clinically determined risk level (low/medium/high) to determine how well the self-assessment tool identifies periodontal risk in the general public. Primary analyses will evaluate agreement and accuracy between questionnaire outputs and the clinical reference label (for example, diagnostic accuracy measures and agreement statistics).
This study does not assign any treatment or preventive intervention. Study activities include completion of an online questionnaire and a same-visit periodontal clinical examination. Risks are minimal and may include mild, temporary discomfort or minor bleeding during periodontal probing, as well as potential privacy risks related to collection of questionnaire responses and clinical findings. To protect confidentiality, participants' data will be recorded using a study identifier rather than direct personal identifiers and will be stored in secure, access-controlled systems accessible only to authorized study personnel.
The results of this study are expected to support validation and refinement of the self-assessment tool and inform future efforts to improve early identification of periodontal risk and promote preventive oral health care at the community level.
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Being tested
- Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)
- Keywords
- Periodontal diseases, risk assessment, self-report
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)Other
Participants complete an online self-assessment questionnaire and undergo a same-visit clinical periodontal examination to assign a reference-standard periodontal risk category (low/medium/high). No therapeutic intervention is assigned as part of this observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between self-assessment risk category and clinical periodontal risk category
Agreement between the questionnaire-derived periodontal risk category and the reference-standard clinical periodontal risk category assigned during the same visit. Both classifications will use three ordered categories: low risk, medium risk, and high risk. Agreement will be summarized using weighted kappa and the proportion of exact matches. Weighted kappa ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and values below 0 indicate less agreement than expected by chance.
Measured: Same visit (baseline)
Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification
Overall diagnostic accuracy of the questionnaire-derived periodontal risk classification compared with the clinical reference-standard periodontal risk classification. Accuracy will be calculated as the proportion of correctly classified participants among all participants. The value ranges from 0 to 1, where higher values indicate better classification performance.
Measured: Same visit (baseline)
Sensitivity and Specificity for High-Risk Periodontal Disease Detection
Sensitivity and specificity of the self-assessment questionnaire for identifying high-risk periodontal status compared with the clinical reference-standard classification. High-risk periodontal status will be compared against non-high-risk status, which includes low-risk and medium-risk categories. Sensitivity and specificity each range from 0 to 1, where higher values indicate better diagnostic performance
Measured: Same visit (baseline)
Macro-Averaged F1-Score for Periodontal Risk Classification
Macro-averaged F1-score across the three periodontal risk categories: low risk, medium risk, and high risk. The F1-score is the harmonic mean of precision and recall, calculated separately for each risk category and then averaged equally across categories. The macro-averaged F1-score ranges from 0 to 1, where higher values indicate better classification performance.
Measured: Same visit (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Feb 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
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
- Prospective
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Ahmed M. Alshehri, Universiti Sains Malaysia
- Investigators
- Abdulrahman Ahmed Alshehri, MS, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410351
- Sponsor's protocol ID
- USM/JEPeM/KK/25050469
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (questionnaire responses, clinically assigned periodontal risk category, and relevant derived variables) will be made available to qualified researchers upon reasonable request and approval by the study team and ethics requirements.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning
- ClinicalTrials.gov ID
- NCT07410351
- Acronym / sponsor ID
- USM/JEPeM/KK/25050469
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Keywords
- Periodontal diseases, risk assessment, self-report
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.
Detailed description
Periodontal disease is a common oral health problem that can progress silently and may lead to gum inflammation, tooth loss, and reduced quality of life if not detected and managed early. Many people may not recognize early signs or may delay seeking dental care until symptoms become more noticeable. An online self-assessment tool may help members of the public identify whether they are at higher risk and encourage timely evaluation and preventive care.
This observational study will collect labeled data to evaluate the accuracy of an online periodontal self-assessment tool in the general adult population. Participants will complete a structured online questionnaire that asks about oral and periodontal health symptoms, dental history, oral hygiene practices, and other health-related factors commonly linked to periodontal risk. During the same visit, each participant will undergo a standardized clinical periodontal examination conducted by a trained clinician. The clinical examination will serve as the reference standard to assign a periodontal risk label for each participant, categorized as low, medium, or high risk according to predefined criteria in the study protocol.
The primary purpose of this labeled-data phase is to compare the questionnaire-based assessment with the clinically determined risk level (low/medium/high) to determine how well the self-assessment tool identifies periodontal risk in the general public. Primary analyses will evaluate agreement and accuracy between questionnaire outputs and the clinical reference label (for example, diagnostic accuracy measures and agreement statistics).
This study does not assign any treatment or preventive intervention. Study activities include completion of an online questionnaire and a same-visit periodontal clinical examination. Risks are minimal and may include mild, temporary discomfort or minor bleeding during periodontal probing, as well as potential privacy risks related to collection of questionnaire responses and clinical findings. To protect confidentiality, participants' data will be recorded using a study identifier rather than direct personal identifiers and will be stored in secure, access-controlled systems accessible only to authorized study personnel.
The results of this study are expected to support validation and refinement of the self-assessment tool and inform future efforts to improve early identification of periodontal risk and promote preventive oral health care at the community level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from members of the general public who are scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and study procedures will take place at the center during the scheduled screening visit.
Key inclusion criteria (5 listed)
- Adult aged 18 years or older
- Able to read and understand the study information and provide informed consent
- Able to complete the online questionnaire independently (on a smartphone/tablet/computer)
- Willing to undergo a same-visit clinical periodontal examination
- Has natural teeth present (dentate)
Key exclusion criteria (5 listed)
- Completely edentulous (no natural teeth)
- Currently undergoing active periodontal treatment (e.g., scaling and root planing) or received periodontal therapy within the past [6 months]
- Took systemic antibiotics within the past [3 months]
- Unable to complete the questionnaire or examination due to cognitive impairment, severe illness, or communication barriers that prevent informed consent
- Refuses or is unable to tolerate the periodontal clinical examination
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 |
|---|---|---|
| Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)Participants complete an online self-assessment questionnaire and undergo a same-visit clinical periodontal examination to assign a reference-standard periodontal risk category (low/medium/high). No therapeutic intervention is assigned as part of this observational study. | Other | – |
Primary outcome
Agreement between self-assessment risk category and clinical periodontal risk category
Time frame: Same visit (baseline)
Agreement between the questionnaire-derived periodontal risk category and the reference-standard clinical periodontal risk category assigned during the same visit. Both classifications will use three ordered categories: low risk, medium risk, and high risk. Agreement will be summarized using weighted kappa and the proportion of exact matches. Weighted kappa ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and values below 0 indicate less agreement than expected by chance.
Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification
Time frame: Same visit (baseline)
Overall diagnostic accuracy of the questionnaire-derived periodontal risk classification compared with the clinical reference-standard periodontal risk classification. Accuracy will be calculated as the proportion of correctly classified participants among all participants. The value ranges from 0 to 1, where higher values indicate better classification performance.
Sensitivity and Specificity for High-Risk Periodontal Disease Detection
Time frame: Same visit (baseline)
Sensitivity and specificity of the self-assessment questionnaire for identifying high-risk periodontal status compared with the clinical reference-standard classification. High-risk periodontal status will be compared against non-high-risk status, which includes low-risk and medium-risk categories. Sensitivity and specificity each range from 0 to 1, where higher values indicate better diagnostic performance
Macro-Averaged F1-Score for Periodontal Risk Classification
Time frame: Same visit (baseline)
Macro-averaged F1-score across the three periodontal risk categories: low risk, medium risk, and high risk. The F1-score is the harmonic mean of precision and recall, calculated separately for each risk category and then averaged equally across categories. The macro-averaged F1-score ranges from 0 to 1, where higher values indicate better classification performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (questionnaire responses, clinically assigned periodontal risk category, and relevant derived variables) will be made available to qualified researchers upon reasonable request and approval by the study team and ethics requirements.
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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.
Abdulrahman Ahmed Alshehri, MS principal investigator
Universiti Sains Malaysia
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 and Periodontitis, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Ahmed Alshehri, MS (00966507090251, alshehriabdulrahman3@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between self-assessment risk category and clinical periodontal risk category (time frame: Same visit (baseline)). The study lists 4 primary outcomes in all. 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 5 May 2026.