PeriodontitisNCT06302855
Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care
A study testing dental expertise in people with Periodontitis, run by Karim Gariani.
Trial summary
Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- dental expertise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes
Who cannot join
- last dental visit<1 year
- patient unable to give consent
About this study
Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).
Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.
The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.
- Conditions
- Periodontitis
- Being tested
- dental expertise
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental expertiseDiagnostic test
dental visit based on dental expertise
| Study group | Role | What they receive |
|---|---|---|
| dental visit invited | Active comparator | Patients will only be invited or asked to schedule a complimentary periodontal check-up visit without any previous assessment. Receives: Diagnostic Test: dental expertise |
| dental visit recommended based on dental expertise | Experimental | Patients' oral cavities will be photographed. Based on the remote assessment of periodontitis risk conducted by the same periodontist from the Division of Regenerative Dental Medicine and Periodontology at the University Clinic of Dental Medicine, patients will be invited or asked to schedule a complimentary periodontal check-up visit at the CUMD. The appointment will be arranged directly at the diabetologist's office. Receives: Diagnostic Test: dental expertise |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence of diabetic patients to periodontal
The primary endpoint is to evaluate the adherence of diabetic patients to periodontal care either by informing them orally or after evaluation of their gum health by a periodontist based on a simple photo of their smile.
.
Measured: 1 month
Secondary outcomes (1)
calculate the prevalence of periodontitis
Secondary endpoints are to calculate the prevalence of periodontitis and the accordance in diagnosis between the photo and the clinical examination of the patient.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- 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 PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karim Gariani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim Gariani, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302855
- Sponsor's protocol ID
- 2024-00124
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care
- ClinicalTrials.gov ID
- NCT06302855
- Acronym / sponsor ID
- 2024-00124
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karim GarianiUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).
Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.
The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dental visit invited | Active comparator | Diagnostic Test: dental expertisePatients will only be invited or asked to schedule a complimentary periodontal check-up visit without any previous assessment. |
| dental visit recommended based on dental expertise | Experimental | Diagnostic Test: dental expertisePatients' oral cavities will be photographed. Based on the remote assessment of periodontitis risk conducted by the same periodontist from the Division of Regenerative Dental Medicine and Periodontology at the University Clinic of Dental Medicine, patients will be invited or asked to schedule a complimentary periodontal check-up visit at the CUMD. The appointment will be arranged directly at the diabetologist's office. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 or type 2 diabetes
Key exclusion criteria (2 listed)
- last dental visit<1 year
- patient unable to give 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 |
|---|---|---|
| dental expertisedental visit based on dental expertise | Diagnostic test | dental visit invited, dental visit recommended based on dental expertise |
Primary outcome
adherence of diabetic patients to periodontal
Time frame: 1 month
The primary endpoint is to evaluate the adherence of diabetic patients to periodontal care either by informing them orally or after evaluation of their gum health by a periodontist based on a simple photo of their smile. .
1 secondary outcome
calculate the prevalence of periodontitis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing dental expertise in people with Periodontitis, run by Karim Gariani.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
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?
adherence of diabetic patients to periodontal (time frame: 1 month). 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 12 Mar 2024.