Status:
COMPLETED
Are Diabetics Type 2 More Prone to Dental Caries?
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
The Novo Nordisk UK Research Foundation
Conditions:
Diabetes Mellitus, Type 2
Dental Caries
Eligibility:
All Genders
18+ years
Brief Summary
Background: Diabetes mellitus (DM) is well known for long-term complications to general and oral health. Periodontal disease has a bidirectional association with the development of type 2 diabetes (T2...
Detailed Description
Research purpose: The research question is individuals with Diabetes Mellitus type 2 (T2DM) is more prone to dental caries? Several literature reviews point the lack of solid evidence clear associat...
Eligibility Criteria
Inclusion
- Participants may enter the trial if the following apply:
- Participants who are male or female ≥ 18 years of age.
- For the test group, they have been diagnosed with type 2 Diabetes
- For the control group, participants who are not diagnosed with type 2 Diabetes
- Particiapants having minimum one natural tooth
- They are capable of giving informed consent
- They have the ability to understand and speak English
- They are able and willing to comply with all trial requirements
- They are not participating in another dental trial
- They are not diagnosed for cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia.
- No antibiotics, no steroidal and/or non-steroidal anti-inflammatory medication used during the last 3 weeks
- Participants who are not pregnant and also not breastfeeding
- Participations who are not in another dental study testing different dental products during the previous three months and during the study period
- Participants who are not currently taking Vitamin D supplements
Exclusion
- \- Participants may not enter the trial if ANY of the following apply:
- Participants who are edentulous
- Cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia.
- The presence of any hard or soft tissue tumours in the oral cavity
- Patients undergoing chemo and/or radiation therapy
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Any condition, which in the opinion of the investigator, would preclude participation by the subject (such as cross-infection control risk)
- Participants who are prescribed long-term systematic antibiotics
- Participants who are pregnant and breastfeeding
- Participations who are in another dental study testing different dental products during the previous three months and during the study period
- Participants who had additional fluoride treatment in the past 6/3 months
- Participants who are prescribed to use high fluoridated toothpaste
- Participants who are currently taking Vitamin D supplements
Key Trial Info
Start Date :
December 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04883086
Start Date
December 15 2020
End Date
November 2 2021
Last Update
March 23 2022
Active Locations (1)
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1
Royal London Dental Hospital
London, United Kingdom, E1 2AD