Root caries Oral Health Root caries
Conditions
Interventions
1. Test group will receive dental varnish with CPP-ACP and fluoride (MI varnish, GC)
2. Control group will receive dental varnish with fluoride only (NUPRO Varnish, DENTSPLY)
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female = 18 years of age 3. Minimum one primary root caries (PRC), which is accessible for the diagnostic procedure 4. Participants who agree to return for assessments during the study period 5. Participants who are capable of giving informed constant 6. Saliva sample test showing a quantitative change in unstimulated whole saliva; =0.16 mL/min 7. Ability to carry out oral hygiene practice instruction 8. Participants who agree to use the standard dentifrice (Aquafresh, GSK, 1450 ppm fluoride) with a medium sized toothbrush (Oral-B) that will be provided by the research team 9. Participants are not involved another other clinical study investigating the oral care products 10. Participants not using any other mouthwash/dentifrice/gels/chewing gums/lozenges containing test ingredients and fluoride 11. In the Investigator’s opinion, is able and willing to comply with all trial requirements 12. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial 13. Medically allowable to undergo the baseline and follow-up assessments
Exclusion criteria
Exclusion criteria: 1. No active primary root carious lesions 2. Presence of chronic/aggressive periodontal disease concerning the test tooth in the study tooth (purulent exudates, tooth mobility, and/or extensive bone loss) 3. Participation in another dental study testing different dental products during the previous three months and during the study period 4. Any condition, which in the opinion of the investigator, would preclude participation by the subject (such as cross-infection control risk) 5. Cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia 6. Secondary root carious lesion 7. Hypersensitivity to either milk or one of the test products 8. Test tooth with untreated cavitated proximal or occlusal caries 9. Patient using any other topical agent that may affect the results such as mouthwash, chewing gum and lozenge with active ingredients or antibacterial agents 10. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 11. Significant renal or hepatic impairment 12. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial 13. 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 14. Participants who are prescribed for long-term systematic antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in root caries severity index (scores 0, 1, 2, 3 and 4) at baseline and after 3, 6, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in texture, hardness, cavitation, colour, size and distance from the gingivae at baseline and after 3, 6, and 12 months 2. Change in the fluorescence values at baseline and after 3, 6, and 12 months 3. Correlation of the severity index and fluorescence values at baseline and after 3, 6, and 12 months 4. Correlation of the severity index and saliva properties, including buffering capacity and resting pH, at baseline and after 6 and 12 months 5. Correlation of the severity index and plaque index at baseline and after 3, 6, and 12 months | — |
Countries
United Kingdom
Outcome results
None listed