Plain English Summary
Background and study aims
Sjögren's syndrome is an autoimmune disorder where the body’s immune system attacks glands that secrete fluid, such as the salivary glands. This leads to a reduced production of saliva, making patients more prone to tooth decay (caries). Fluoride varnish is commonly applied onto their teeth for caries prevention. The aim of this study is to investigate the effectiveness of fluoride varnish in caries prevention in this group of patients.
Who can participate?
Sjögren’s syndrome patients aged 18 or over with eight or more natural teeth.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group have their teeth treated with fluoride varnish quarterly and participants in the other group have their teeth treated with a placebo (dummy) gel quarterly. Their teeth are assessed for caries at the start of the study and after 12 and 24 months, along with the amount of Candida (a fungus) and lactobacilli (bacteria) in the mouth.
What are the possible benefits and risks of participating
Participants are provided with free-of-charge dental examinations, oral hygiene instructions, dental treatment (restorations and prostheses), and periodontal (gum) treatment if needed. There is a temporary effect of fluoride varnish as it leaves a yellow film on the teeth for several hours after application unless it is removed by brushing.
Where is the study run from?
Prince Philip Dental Hospital, Faculty of Dentistry, The University of Hong Kong (Hong Kong)
When is the study starting and how long is it expected to run for?
January 2009 to October 2013
Who is funding the study
Research Grants Council of Hong Kong (Hong Kong)
Who is the main contact?
Dr Katherine Leung
Trial website
Contact information
Type
Scientific
Primary contact
Dr Katherine Leung
ORCID ID
http://orcid.org/0000-0003-3703-8232
Contact details
Prosthodontics
Prince Philip Dental Hospital
34 Hospital Road
Sai Ying Pun
Hong Kong
-
Hong Kong
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients
Acronym
Study hypothesis
Quarterly applied fluoride varnish can prevent caries development in Sjögren’s syndrome patients.
Ethics approval
Institutional Review Boards of the University of Hong Kong/Hospital Authority Hong Kong West and Kowloon Central and East Clusters, 23/04/2008, refs: UW 08-167 and KC/KE-10-0014/ER-2
Study design
Randomized double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Caries development in Sjögren’s syndrome patients
Intervention
Sjögren’s syndrome patients were randomly assigned to receive either professionally applied fluoride varnish or placebo gel quarterly. Development and arrest of caries at the coronal and root surfaces were recorded at 12 months and 24 months and compared to that of the baseline. Effect of fluoride varnish on oral Candida and lactobacilli colonization was explored by comparing baseline oral microbiological assessments to data obtained at 12 months and 24 months.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Caries at the coronal and root surface evaluated using the International Caries Detection and Assessment System (ICDAS) at 12 months and 24 months
Secondary outcome measures
Counts of lactobacilli and Candida (expressed as colony forming units per milliliter (CFU/ml) in salivary samples and colony forming units per gram in dental plaque samples) evaluated at 12 months and 24 months
Overall trial start date
03/01/2009
Overall trial end date
30/10/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinical diagnosis of Sjögren’s syndrome established using the American-European Consensus Group (AECG) criteria at least 6 months before the commencement of this study
2. Age 18 or above
3. Had 8 or more natural teeth present
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Severe periodontal disease (e.g., periodontal pockets were deeper than 6 mm) at two or more sextants
2. Received therapeutic irradiation to the head and neck region
3. Had concurrent systemic illness (except connective tissue disorder associated with secondary Sjögren’s syndrome)
4. Taking medication that altered salivary flow
5. Had participated in a clinical trial within 6 months before commencement of this trial
Recruitment start date
11/06/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Prince Philip Dental Hospital
Faculty of Dentistry
The University of Hong Kong
34 Hospital Road
Sai Ying Pun
-
Hong Kong
Funders
Funder type
Research council
Funder name
Research Grants Council, University Grants Committee
Alternative name(s)
RGC, UGC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Hong Kong
Results and Publications
Publication and dissemination plan
A manuscript has been submitted to be considered for publication
Intention to publish date
08/12/2016
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27664129