Holistic approach to investigate dental caries in diabetes patients

Not Applicable

• Conditions: Dental caries; Oral Health

• Registration Number: ISRCTN89652137
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-23
• Last Update Posted: 29 October 2019
• Study Completion: 2022-09-11

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

1. Participants who are male or female =18 years of age
2. For the test group, they have been diagnosed with type 2 diabetes
3. For the control group, participants who are not diagnosed with type 2 diabetes
4. Participants having minimum one natural tooth
5. Capable of giving informed consent
6. Ability to understand and speak English
7. Able and willing to comply with all trial requirements
8. Not participating in another dental trial
9. Not diagnosed with cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia
10. No antibiotic, no steroidal and/or non-steroidal anti-inflammatory medication used during the last 3 weeks
11. Not pregnant or breastfeeding
12. Not in another dental study testing different dental products during the previous 3 months and during the study period
13. Not currently taking Vitamin D supplements

Exclusion Criteria

1. Participants who are edentulous
2. Cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia
3. The presence of any hard or soft tissue tumours in the oral cavity
4. Patients undergoing chemo and/or radiation therapy
5. 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
6. Any condition, which in the opinion of the investigator, would preclude participation by the subject (such as cross-infection control risk)
7. Participants who are prescribed long-term systemic antibiotics
8. Participants who are pregnant or breastfeeding
9. Participations who are in another dental study testing different dental products during the previous three months and during the study period
10. Participants who had additional fluoride treatment in the past 6/3 months
11. Participants who are prescribed to use high fluoridated toothpaste
12. Participants who are currently taking Vitamin D supplements

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of dental caries assessed using the International Caries Detection and Assessment System (ICDAS) and severity index during the assessment process.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Dental caries risk levels measured using Caries Management by Risk Assessment (CAMBRA) during the examination stage<br> 2. Streptococcus mutans, Lactobacillus bacteria and total bacterial load in supragingival plaque measured using a real-time PCR assay<br> 3. Unstimulated saliva flow rate measured using saliva weight<br> 4. Saliva pH and buffer capacity using the saliva-check buffer testing mat kit<br> 5. Saliva Spinnbarkeit (fibrosity) measured using the NevaMeter device<br> 6. Stimulated whole saliva, total proteins, total antioxidant capacity and nitrate oxide measured using assay kit where the reaction is measured by spectrophotometer<br> 7. Saliva electrolytes measured using Ion Selective Electrode (ISE) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)<br> 8. Blood HbA1c and vitamin D levels measured using specific assay kits<br>