Effect of Dental Varnishes on Root Caries in Patients with Xerostomia
Research type
Research Study
Full title
Effect of Dental Varnish Containing fluoride with Casein Phosphopeptide–Amorphous Calcium Phosphate for the Management of Root Caries in Patients with Xerostomia: A 12-month Randomised Clinical Trial
IRAS ID
203165
Contact name
Aylin Baysan
Contact email
Sponsor organisation
QMUL
ISRCTN Number
ISRCTN49336428
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Root caries is still been considered as the most important global oral health burden in the 21 century. Patients with dry mouth are also at high risk of developing root caries which possess clinical challenges in clinical practice.
Dry mouth affects the quality of life and is a high-risk factor for dental disease and tooth loss. Wearing dentures can also be extremely uncomfortable for dry mouth patients as it can easily traumatise the dry lining of the mouth.
It is, therefore, important to detect root caries early and manage these lesions with noninvasive management strategies and help them to retain their natural teeth for as long as possible.
This clinical trial will be preceded by a preliminary ex-vivo study to assess the effectiveness of three dental varnishes which will potentially be tested in this clinical study. These teeth will be collected from patients who agree to donate their extracted teeth and sign the consent form at Barts Health Dental Hospital.
The present study will therefore investigate whether a dental varnish can be effective in arresting/reversing root caries in dry mouth patients. This will be achieved by comparing the results of multiple applications of dental varnishes containing fluoride with additional active ingredients in a group of dry mouth patients for a period of one year. We will also look how well the product is accepted by patients.
There will be clinical assessment of root caries and use detection systems to quantify the changes in lesion severity over a period of one year.
This clinical study will be conducted at the Dental Hospital, Barts and the London, Queen Mary's School of Medicine and Dentistry. A total of 80 patients will be recruited and randomly allocated to the test and positive control groups with 40 patients each.The study period will be one year.
REC name
HSC REC A
REC reference
16/NI/0101
Date of REC Opinion
7 Jun 2016
REC opinion
Further Information Favourable Opinion