Condition category
Oral Health
Date applied
13/09/2019
Date assigned
23/09/2019
Last edited
26/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ashwaq Alkahtani

ORCID ID

Contact details

Queen Mary University of London
School of Medicine and Dentistry
Dental Hospital
Barts and The London
London
E1 2AD
United Kingdom
+44 (0)20 7882 8975
a.s.s.alkahtani@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Holistic approach to investigate protective and risk factors for dental caries in patients with or without diabetes type 2

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

09/07/2018

Overall trial end date

11/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

182

Participant 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

Recruitment start date

16/12/2019

Recruitment end date

11/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Health NHS Trust/The Royal London Dental Hospital
The Royal London Hospital Whitechapel Rd Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7275/6574
research.governance@qmul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Novo Nordisk UK Research Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Saudi Arabia Cultural Bureau in London

Alternative name(s)

Royal Embassy of Saudi Arabia Cultural Bureau in London, Royal Embassy of Saudi Arabia - Cultural Bureau in London, Royal Embassy of Saudi Arabia Cultural Bureau, SACB

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The data from this study will be analysed and the results will be published in a timely manner. The main output will be researcher papers in a scientific journal as well as being presented at scientific meetings.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/09/2019: Internal review. 20/09/2019: Trial's existence confirmed by the Novo Nordisk UK Research Foundation.