GingivitisNCT07727421
Artificial Intelligence for the Diagnosis of Gingivitis
An observational study of Gingivitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
this study aims to use AI to diagnose the stages of gingivitis Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Artificial intelligence Diagnostic Model
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of patients who attended dental clinics at Al-Azhar university and were evaluated for periodontal conditions, and whose digital clinical photographs or dental radiographs are utilized for training and validating the artificial intelligence model.
Who may be able to join
- patients in both genders within age range of 15-50 years
- smokers patients
- patient treated for stable systemic disease
Who cannot join
- pregnant women to avoid risk of panoramic x-ray
- patient with active systemic diseases
- patient taking antibiotics
- patient receiving anticancer therapy
- patient with excessive gingival hyperplasia and with extensive melanin pigmentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Image Analysis as a Primary Indicator for Gingival Inflammation Grading Using Artificial Intelligence
this study aims to use AI to diagnose the stages of gingivitis
Read the detailed description
I take clinical photography of patient mouth have gingivitis by digital camera and do intra oral panoramic x-rays to make sure of there is no bone loss then I enter patient data in AI model to grading them to mild ,moderate ,sever gingivitis
- Conditions
- Gingivitis
- Being tested
- Artificial intelligence Diagnostic Model
- Keywords
- deep learning, Artificial Intelligence, clinical photography, dental radiographes
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence Diagnostic ModelDiagnostic test
An artificial intelligence model trained to analyze digital photographs/radiographs to automatically classify and diagnose the stages of periodontal disease
| Study group | Role | What they receive |
|---|---|---|
| periodontal disease patients | This group consists of individuals diagnosed with various stages of periodontal disease. Digital clinical photographs and/or dental radiographs of their gums will be evaluated and analyzed using an Artificial Intelligence (AI) model to automatically classify and diagnose the specific stages of gum inflammation. Receives: Diagnostic Test: Artificial intelligence Diagnostic Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the AI model
The primary outcome is to evaluate the diagnostic accuracy, sensitivity, and specificity of the AI model in detecting and staging periodontal disease compared to clinical/radiographic expert diagnosis.
Measured: during the baseline clinical and radiographic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Mar 2025
- Primary completion1 Apr 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mamdouh saad eldien, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727421
- Sponsor's protocol ID
- OMPDR-108-1O
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data collected during the trial, including baseline characteristics, clinical outcomes, and laboratory results, will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Image Analysis as a Primary Indicator for Gingival Inflammation Grading Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07727421
- Acronym / sponsor ID
- OMPDR-108-1O
- Conditions
- Gingivitis
- Keywords
- deep learning, Artificial Intelligence, clinical photography, dental radiographes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Jul 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 study aims to use AI to diagnose the stages of gingivitis
Detailed description
I take clinical photography of patient mouth have gingivitis by digital camera and do intra oral panoramic x-rays to make sure of there is no bone loss then I enter patient data in AI model to grading them to mild ,moderate ,sever gingivitis
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontal disease patients | – | Diagnostic Test: Artificial intelligence Diagnostic ModelThis group consists of individuals diagnosed with various stages of periodontal disease. Digital clinical photographs and/or dental radiographs of their gums will be evaluated and analyzed using an Artificial Intelligence (AI) model to automatically classify and diagnose the specific stages of gum inflammation. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of patients who attended dental clinics at Al-Azhar university and were evaluated for periodontal conditions, and whose digital clinical photographs or dental radiographs are utilized for training and validating the artificial intelligence model.
Key inclusion criteria (3 listed)
- patients in both genders within age range of 15-50 years
- smokers patients
- patient treated for stable systemic disease
Key exclusion criteria (5 listed)
- pregnant women to avoid risk of panoramic x-ray
- patient with active systemic diseases
- patient taking antibiotics
- patient receiving anticancer therapy
- patient with excessive gingival hyperplasia and with extensive melanin pigmentation
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 |
|---|---|---|
| Artificial intelligence Diagnostic ModelAn artificial intelligence model trained to analyze digital photographs/radiographs to automatically classify and diagnose the stages of periodontal disease | Diagnostic test | periodontal disease patients |
Primary outcome
Diagnostic Accuracy of the AI model
Time frame: during the baseline clinical and radiographic assessment
The primary outcome is to evaluate the diagnostic accuracy, sensitivity, and specificity of the AI model in detecting and staging periodontal disease compared to clinical/radiographic expert diagnosis.
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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data collected during the trial, including baseline characteristics, clinical outcomes, and laboratory results, will be made available upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Gingivitis, run by Al-Azhar University at 1 site in Egypt.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the AI model (time frame: during the baseline clinical and radiographic assessment). 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 27 Jul 2026.