Caries,DentalNCT06701565
Coronal and Radicular Caries Prevalence and Related Risk Factor in Diabetic Patient
An observational study of Caries,Dental and Caries Root, run by Cairo University.
Trial summary
This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Caries,Dental, Caries Root, Diabetes Mellitus, Type 2
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Jun 2025
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 1. Patient whose age between 30-65 2. Diabetic patients 3. Patient consulting in the outpatient clinic 4. Co-operative patient 5. Males \& Females 6. Egyptian
Who may be able to join
- Patient whose age between 30-65
- Diabetic patients
- Patient consulting in the outpatient clinic
- Co-operative patient
- Males \& Females
- Egyptian
Who cannot join
- Patients under or over this age group
- Lack of compliance
- Disabilities
- Pregnant women
About this study
Official title: Coronal and Radicular Caries Prevalence With Related Risk Factors Among Middle Age Type II Diabetic Patients Attending National Institute of Diabetes and Endocrinology: a Hospital Based Cross Sectional Study
This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.
- Conditions
- Caries,Dental, Caries Root, Diabetes Mellitus, Type 2
- Medical subject headings
- Dental Caries, Root Caries, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controlled type 2 diabetes | Not described | |
| Uncontrolled type 2 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of coronal caries
DMFT Index developed by World Health Organization (WHO) using number scores and percentage
Measured: One year
prevalence of radicular caries
Radicular caries by International Caries and Assessment System (ICDAS II)
Measured: One year
Secondary outcomes (4)
Blood Glucose level
Blood tests of glycated hemoglobin
Measured: One year
Salivary flow
Graduated test tube
Measured: One year
Salivary pH
PH indicator
Measured: One year
Caries risk related factors
WHO oral health questionnaire for adults 2013
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cross-sectional
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Osama Rashid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701565
- Sponsor's protocol ID
- Caries Prevalence and Diabetes
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronal and Radicular Caries Prevalence With Related Risk Factors Among Middle Age Type II Diabetic Patients Attending National Institute of Diabetes and Endocrinology: a Hospital Based Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06701565
- Acronym / sponsor ID
- Caries Prevalence and Diabetes
- Conditions
- Caries,Dental, Caries Root, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 22 Nov 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.
This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled type 2 diabetes | – | – |
| Uncontrolled type 2 diabetes | – | – |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1. Patient whose age between 30-65 2. Diabetic patients 3. Patient consulting in the outpatient clinic 4. Co-operative patient 5. Males \& Females 6. Egyptian
Key inclusion criteria (6 listed)
- Patient whose age between 30-65
- Diabetic patients
- Patient consulting in the outpatient clinic
- Co-operative patient
- Males \& Females
Key exclusion criteria (4 listed)
- Patients under or over this age group
- Lack of compliance
- Disabilities
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of coronal caries
Time frame: One year
DMFT Index developed by World Health Organization (WHO) using number scores and percentage
prevalence of radicular caries
Time frame: One year
Radicular caries by International Caries and Assessment System (ICDAS II)
4 secondary outcomes
Blood Glucose level
Time frame: One year
Salivary flow
Time frame: One year
Salivary pH
Time frame: One year
Caries risk related factors
Time frame: one year
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 4 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries,Dental and Caries Root, run by Cairo University.
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 6 inclusion and 4 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 4 Dec 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?
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?
prevalence of coronal caries (time frame: One year). The study lists 2 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 4 Dec 2024.