Holistic approach to investigate dental caries in diabetes patients
| ISRCTN | ISRCTN89652137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89652137 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Queen Mary University of London (UK) |
| Funders | Novo Nordisk UK Research Foundation, Saudi Arabia Cultural Bureau in London |
- Submission date
- 13/09/2019
- Registration date
- 23/09/2019
- Last edited
- 26/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims:
Diabetes mellitus affects almost 4 million people in the UK, and by 2025, it is estimated that 5 million people will have diabetes. Diabetes can cause oral health problems including dry mouth, tooth decay, gum problems, tongue sores and mouth ulcers. This study aims to investigate factors that might promote or reduce dental decay in patients with or without type 2 diabetes, including oral hygiene behaviour, saliva properties, bacteria found in the mouth, blood glucose levels and vitamin D levels.
Who can participate?
Non-diabetic adults and adults with type 2 diabetes
What does the study involve?
Participants will fill in a questionnaire on their lifestyle and how they look after their teeth. They will also provide a saliva (spit) sample. A dentist will examine their teeth, including taking X-rays if needed, and will take a sample of dental plaque. A nurse will take a blood sample. All participants will receive instruction on oral hygiene along with a free toothbrush and toothpaste.
What are the possible benefits and risks of participating?
Participants will benefit from an examination of their saliva and teeth conditions. They will also be able to verify their blood glucose, vitamin D level and if they are suffering from hyposalivation (reduced saliva, leading to a dry mouth). Teeth will be examined for tooth decay. In addition, the participants will be assessed on their risk of developing new decay. Finally, oral hygiene (cleaning the teeth and mouth) instructions with a free toothpaste and toothbrush will be provided.
Where is the study run from?
Bart’s Health NHS Trust hospitals, Royal London Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2018 to September 2019
Who is funding the study?
This study is part of a PhD study which is fully funded by the Saudi Arabia Cultural Bureau in Britain (SACB). Part of the funding was awarded for this clinical project by the Novo Nordisk UK Research Foundation.
Who is the main contact?
1. Dr Aylin Baysan, a.baysan@qmul.ac.uk
2. Ashwaq Alkahtani, a.s.s.alkahtani@qmul.ac.uk
Contact information
Scientific
Queen Mary University of London
School of Medicine and Dentistry
Dental Hospital
Barts and The London
London
E1 2AD
United Kingdom
| Phone | +44 (0)20 7882 8975 |
|---|---|
| a.s.s.alkahtani@qmul.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational case-control study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Holistic approach to investigate protective and risk factors for dental caries in patients with or without diabetes type 2 |
| Study objectives | Primary outcome: The extent of dental caries in participants either with diabetes type 2 or without diabetes type 2. Holistic investigation of most potential protective and risk factors of dental caries among individuals with diabetes type 2 by the employment of clinical, salivary, Vitamin D, blood and microbial (dental plaque) analyses. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dental caries |
| Intervention | All the following assessments will be carried out: 1. Medical and dental history 2. Questionnaire of relevant protective and risk factors for dental caries 3. Unstimulated Whole Saliva tests (USWS) to measure flow rate, pH, buffer capacity and Spinnbarkeit 4. Stimulated whole saliva sample collecting for later saliva physical and chemical analyses (salivary osmolality, total proteins, total antioxidant capacity, nitrate oxide and saliva electrolytes (calcium, phosphate, sodium, potassium, fluoride and zinc) 5. A blood sample will be obtained by a registered nurse to do a glycated haemoglobin test (HbA1c) to measure glucose control and Vitamin D level 6. Dental plaque scoring 7. Supragingival plaque sample collecting for later analyses or total bacterial load, Streptococcus mutans count and Lactobacillus count A further assessment will follow supragingival and subgingival debridement (if required) using ultrasonic scaler with polishing using the prophylaxis paste (NUPRO DENTSPLY, Germany). 8. Dental caries (coronal and root) examination via ICDAS-II index and root severity index 9. Dental caries detection using laser fluorescence evaluator (SoproLife ®, Acteon, La Ciotat, France) 10. Dental caries risk assessment by CAMBRA model 11. Oral hygiene instructions with a free toothpaste and toothbrush |
| Intervention type | Other |
| Primary outcome measure(s) |
Extent of dental caries assessed using the International Caries Detection and Assessment System (ICDAS) and severity index during the assessment process. |
| Key secondary outcome measure(s) |
1. Dental caries risk levels measured using Caries Management by Risk Assessment (CAMBRA) during the examination stage |
| Completion date | 11/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 182 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/12/2019 |
| Date of final enrolment | 11/04/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Whitechapel Rd
Whitechapel
London
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/09/2019: Internal review.
20/09/2019: Trial's existence confirmed by the Novo Nordisk UK Research Foundation.
