PreDiabetesNCT06453278
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
An observational study of PreDiabetes and Type2diabetes, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study is conducted to evaluate validity of Diabetes Risk Assessment in Dentistry Score (DDS) in Indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- PreDiabetes, Type2diabetes, Periodontitis
- Type of treatment
- Pill or oral medicine
- How many people
- 1,746 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2024to Apr 2026
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study participants will be drawn from consecutive eligible adults attending the regular out patient department (OPD) of PGIDS, Rohtak. All individuals will be required to provide written informed consent before enrolment in the study. Inclusion criteria-adults aged ≥ 40 years Exclusion criteria- 1. Individuals with existing physician-diagnosed diabetes (of any kind) 2. Pregnant females
Who may be able to join
None listed.
Who cannot join
- Individuals with existing physician-diagnosed diabetes (of any kind)
- Pregnant females
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
ADITI SANGWAN, MDS, 09996002408, aditidalal86@yahoo.co.in
About this study
Official title: Validation of Diabetes Risk Assessment in Dentistry Score (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
This study is conducted to evaluate validity of Diabetes Risk Assessment in Dentistry Score (DDS) in Indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. The DDS score of the patient will be correlated with the HbA1c levels and periodontal status of the patient. Such a study has been conducted in Germany but none has been validated in Indian population. Hence this study aims to assess the performance of DDS screening tool in Indian population.
Read the detailed description
BACKGROUND- Most of the models for T2DM risk assessment exist for use in medical settings and include data which is commonly unavailable to dentists. To overcome the limitation of applicability of existing diabetes-risk assessment tools in dental settings, the Diabetes Risk Assessment in Dentistry Score (DDS) was developed utilizing measures routinely available to dentists. It has been developed and validated in a German population and found to perform broadly at par with those validated for use in medical settings. RATIONALE-Models developed in a specific population need to be validated in other populations before they can be adopted. The DDS screening tool has not been validated in Indian population till date. OBJECTIVES- To assess performance of DDS screening tool in predicting the risk of prediabetes and type 2 diabetes mellitus among individuals seeking dental consultation in Indian population. METHODS-The study participants will include individuals seeking dental consultation at a university teaching hospital in India. All participants will undergo DDS risk-assessment followed by measurement of serum HbA1c levels to establish diagnosis of health, prediabetes or undiagnosed T2DM. EXPECTED OUTCOMES-It is expected that the DDS screening model performs well in Indian population, with scope for incorporation of the model during regular dental visits.
- Conditions
- PreDiabetes, Type2diabetes, Periodontitis
- Medical subject headings
- Prediabetic State, Periodontitis
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 |
|---|---|---|
| The study group will comprise of consenting adults aged 40 years and above. | A) INTERVIEW Demographic data, family history of type 2 diabetes mellitus and periodontal treatment history is obtained. BODY MASS INDEX (BMI) CALCULATION C) ORAL EXAMINATION-POCKET PROBING DEPTH (PPD) MEASUREMENT PPD Measurement of PPD will be done using a periodontal probe and mouth mirror. Measurement will be done on all teeth present in the mouth (except third molars) at six sites per tooth: mesio-buccal, mid-buccal, distobuccal, mesio-lingual, mid-lingual and distolingual. The number of sites with ≥5-mm probing pocket depth will be recorded on the DDS proforma. The total DDS point score will be obtained by adding all individual variable scores, ranging from 0 to 22. BIOCHEMICAL MEASUREMENT ( HbA1c levels in blood): All participants will be asked for providing blood sample for evaluation of HbA1c levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate DDS score with HbA1c levels in Indian population.
Consecutive patients visiting the dental clinic will be asked to answer questions regarding symptoms of diabetes and glycemic control in an interview format. Blood samples from the patients will then be collected and Hba1c levels of the participant will be determined.
Measured: 15-18 months
To determine prevalence of prediabetes and undiagnosed type 2 diabetes in dental patients.
Screening for risk of diabetes will be done by interviewing the patients visiting the dental out patient department. The DDS risk score for the patient will be calculated and prevalence of prediabetic and undiagnosed cases of type 2 diabetes mellitus will be analyzed.
Measured: 15-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ADITI SANGWAN, MDS, Principal investigator, Post graduate institute of Dental Sciences ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453278
- Sponsor's protocol ID
- DR.ADITIPERIO
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Diabetes Risk Assessment in Dentistry Score (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
- ClinicalTrials.gov ID
- NCT06453278
- Acronym / sponsor ID
- DR.ADITIPERIO
- Conditions
- PreDiabetes, Type2diabetes, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,746 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Jun 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 is conducted to evaluate validity of Diabetes Risk Assessment in Dentistry Score (DDS) in Indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. The DDS score of the patient will be correlated with the HbA1c levels and periodontal status of the patient. Such a study has been conducted in Germany but none has been validated in Indian population. Hence this study aims to assess the performance of DDS screening tool in Indian population.
Detailed description
BACKGROUND- Most of the models for T2DM risk assessment exist for use in medical settings and include data which is commonly unavailable to dentists. To overcome the limitation of applicability of existing diabetes-risk assessment tools in dental settings, the Diabetes Risk Assessment in Dentistry Score (DDS) was developed utilizing measures routinely available to dentists. It has been developed and validated in a German population and found to perform broadly at par with those validated for use in medical settings. RATIONALE-Models developed in a specific population need to be validated in other populations before they can be adopted. The DDS screening tool has not been validated in Indian population till date. OBJECTIVES- To assess performance of DDS screening tool in predicting the risk of prediabetes and type 2 diabetes mellitus among individuals seeking dental consultation in Indian population. METHODS-The study participants will include individuals seeking dental consultation at a university teaching hospital in India. All participants will undergo DDS risk-assessment followed by measurement of serum HbA1c levels to establish diagnosis of health, prediabetes or undiagnosed T2DM. EXPECTED OUTCOMES-It is expected that the DDS screening model performs well in Indian population, with scope for incorporation of the model during regular dental visits.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study group will comprise of consenting adults aged 40 years and above. | – | –A) INTERVIEW Demographic data, family history of type 2 diabetes mellitus and periodontal treatment history is obtained. BODY MASS INDEX (BMI) CALCULATION C) ORAL EXAMINATION-POCKET PROBING DEPTH (PPD) MEASUREMENT PPD Measurement of PPD will be done using a periodontal probe and mouth mirror. Measurement will be done on all teeth present in the mouth (except third molars) at six sites per tooth: mesio-buccal, mid-buccal, distobuccal, mesio-lingual, mid-lingual and distolingual. The number of sites with ≥5-mm probing pocket depth will be recorded on the DDS proforma. The total DDS point score will be obtained by adding all individual variable scores, ranging from 0 to 22. BIOCHEMICAL MEASUREMENT ( HbA1c levels in blood): All participants will be asked for providing blood sample for evaluation of HbA1c levels. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants will be drawn from consecutive eligible adults attending the regular out patient department (OPD) of PGIDS, Rohtak. All individuals will be required to provide written informed consent before enrolment in the study. Inclusion criteria-adults aged ≥ 40 years Exclusion criteria- 1. Individuals with existing physician-diagnosed diabetes (of any kind) 2. Pregnant females
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Individuals with existing physician-diagnosed diabetes (of any kind)
- Pregnant females
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
To correlate DDS score with HbA1c levels in Indian population.
Time frame: 15-18 months
Consecutive patients visiting the dental clinic will be asked to answer questions regarding symptoms of diabetes and glycemic control in an interview format. Blood samples from the patients will then be collected and Hba1c levels of the participant will be determined.
To determine prevalence of prediabetes and undiagnosed type 2 diabetes in dental patients.
Time frame: 15-18 months
Screening for risk of diabetes will be done by interviewing the patients visiting the dental out patient department. The DDS risk score for the patient will be calculated and prevalence of prediabetic and undiagnosed cases of type 2 diabetes mellitus will be analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
ADITI SANGWAN, MDS principal investigator
Post graduate institute of Dental Sciences ROHTAK
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 PreDiabetes and Type2diabetes, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 0 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 11 Jun 2024. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ADITI SANGWAN, MDS (09996002408, aditidalal86@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate DDS score with HbA1c levels in Indian population. (time frame: 15-18 months). 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 11 Jun 2024.