Periodontal DiseasesNCT07397104
Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population
An observational study of Periodontal Diseases and Periodontitis, run by Universiti Sains Malaysia.
Trial summary
This observational study will evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. 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?
- Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)
- How many people
- 291 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 29 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 adults scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and all study procedures will take place at the center during the scheduled screening visit.
Who may be able to join
- Age 18 years or older
- Able to provide informed consent
- Able to complete the self-reported periodontal questionnaire
- Willing to undergo a same-visit clinical periodontal examination
Who cannot join
- Less than ten teeth present
- Any condition that makes periodontal probing unsafe, as judged by the clinician according to local policy
- Unable to complete study procedures or provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity of a Self-Reported Questionnaire for Periodontal Status in a Saudi Population: A Cross-Sectional Clinical Validation Study
This observational study will evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. The study will compare questionnaire-based results with clinical examination findings to assess diagnostic accuracy and agreement.
Read the detailed description
This observational, cross-sectional clinical validation study will assess the validity of a self-reported periodontal questionnaire (CDC-AAP self-report items) among adults attending scheduled screening appointments at Asir Specialized Dental Center in Abha, Saudi Arabia. At the screening visit, participants will complete the self-reported questionnaire. During the same visit, trained clinicians will perform a standardized full mouth clinical periodontal examination, which will serve as the reference standard for determining periodontal status and/or periodontal disease categories according to predefined clinical criteria in the study protocol.
The primary objective is to determine how accurately the self-reported questionnaire identifies clinically determined periodontal status. Questionnaire responses and any questionnaire-derived classification will be compared with clinical examination results to estimate diagnostic accuracy (e.g., sensitivity, specificity, and overall accuracy) and to assess agreement between questionnaire-based and clinically based classifications. Additional outcomes may include feasibility measures such as questionnaire completion rates and missing data patterns. Data will be recorded using study identifiers and stored in secure, access-controlled systems to protect confidentiality. Participation does not involve assignment to any treatment; it consists only of completing a questionnaire and undergoing a same-visit periodontal examination.
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Being tested
- Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)
- Keywords
- Periodontal disease, Validity, self-reported
- 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.
Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)Other
Data collection procedures to validate questionnaire-based periodontal status; no therapeutic intervention is assigned.
| Study group | Role | What they receive |
|---|---|---|
| Adults attending screening appointments (self-report + same-visit clinical exam) | Participants scheduled for screening appointments at Asir Specialized Dental Center will complete a self-reported periodontal questionnaire (CDC-AAP items). During the same visit, a trained clinician will perform a standardized clinical periodontal examination to determine periodontal status (full mouth periodontal examination based on CDC/AAP and EFP case definitions). Questionnaire results will be compared with the clinical findings to evaluate validity. Receives: Other: Self-reported periodontal questionnaire and clinical periodontal examination (reference standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status
Accuracy of the self-reported periodontal questionnaire in identifying clinically determined periodontal status based on the same-visit clinical periodontal examination (reference standard). Diagnostic performance will be summarized using standard measures such as sensitivity, specificity, and area under the ROC curve, as applicable to the questionnaire-derived classification.
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 posted9 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion29 Aug 2026 (estimated)
- Study completion29 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
- Cross-sectional
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Principal investigator, Abdulrahman Ahmed M. Alshehri, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397104
- Sponsor's protocol ID
- F3-12-2025
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, controlled access.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Self-Reported Questionnaire for Periodontal Status in a Saudi Population: A Cross-Sectional Clinical Validation Study
- ClinicalTrials.gov ID
- NCT07397104
- Acronym / sponsor ID
- F3-12-2025
- Conditions
- Periodontal Diseases, Periodontitis, Gingivitis
- Keywords
- Periodontal disease, Validity, self-reported
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 9 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 evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. The study will compare questionnaire-based results with clinical examination findings to assess diagnostic accuracy and agreement.
Detailed description
This observational, cross-sectional clinical validation study will assess the validity of a self-reported periodontal questionnaire (CDC-AAP self-report items) among adults attending scheduled screening appointments at Asir Specialized Dental Center in Abha, Saudi Arabia. At the screening visit, participants will complete the self-reported questionnaire. During the same visit, trained clinicians will perform a standardized full mouth clinical periodontal examination, which will serve as the reference standard for determining periodontal status and/or periodontal disease categories according to predefined clinical criteria in the study protocol.
The primary objective is to determine how accurately the self-reported questionnaire identifies clinically determined periodontal status. Questionnaire responses and any questionnaire-derived classification will be compared with clinical examination results to estimate diagnostic accuracy (e.g., sensitivity, specificity, and overall accuracy) and to assess agreement between questionnaire-based and clinically based classifications. Additional outcomes may include feasibility measures such as questionnaire completion rates and missing data patterns. Data will be recorded using study identifiers and stored in secure, access-controlled systems to protect confidentiality. Participation does not involve assignment to any treatment; it consists only of completing a questionnaire and undergoing a same-visit periodontal examination.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults attending screening appointments (self-report + same-visit clinical exam) | – | Other: Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)Participants scheduled for screening appointments at Asir Specialized Dental Center will complete a self-reported periodontal questionnaire (CDC-AAP items). During the same visit, a trained clinician will perform a standardized clinical periodontal examination to determine periodontal status (full mouth periodontal examination based on CDC/AAP and EFP case definitions). Questionnaire results will be compared with the clinical findings to evaluate validity. |
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 adults scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and all study procedures will take place at the center during the scheduled screening visit.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Able to provide informed consent
- Able to complete the self-reported periodontal questionnaire
- Willing to undergo a same-visit clinical periodontal examination
Key exclusion criteria (3 listed)
- Less than ten teeth present
- Any condition that makes periodontal probing unsafe, as judged by the clinician according to local policy
- Unable to complete study procedures or provide informed consent
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 |
|---|---|---|
| Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)Data collection procedures to validate questionnaire-based periodontal status; no therapeutic intervention is assigned. | Other | Adults attending screening appointments (self-report + same-visit clinical exam) |
Primary outcome
Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status
Time frame: Same-visit (baseline)
Accuracy of the self-reported periodontal questionnaire in identifying clinically determined periodontal status based on the same-visit clinical periodontal examination (reference standard). Diagnostic performance will be summarized using standard measures such as sensitivity, specificity, and area under the ROC curve, as applicable to the questionnaire-derived classification.
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 11 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified, controlled access.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontitis, run by Universiti Sains Malaysia.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status (time frame: Same-visit (baseline)). 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 11 Feb 2026.