Effect of dental varnishes on root caries in patients with xerostomia

Not Applicable

Completed

• Conditions: Root caries; Oral Health

• Registration Number: ISRCTN49336428
• 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: 2016-02-10
• Study Completion: 2018-01-01
• Last Update Posted: 29 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified