Clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients

ISRCTN ISRCTN85164658
DOI https://doi.org/10.1186/ISRCTN85164658
Secondary identifying numbers N/A
Submission date
08/09/2016
Registration date
09/09/2016
Last edited
26/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Katherine Leung
Scientific

Prosthodontics
Prince Philip Dental Hospital
34 Hospital Road
Sai Ying Pun
Hong Kong
-
Hong Kong

ORCiD logoORCID ID 0000-0003-3703-8232

Study information

Study designRandomized double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients
Study objectivesQuarterly applied fluoride varnish can prevent caries development in Sjögren’s syndrome patients.
Ethics approval(s)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
Health condition(s) or problem(s) studiedCaries development in Sjögren’s syndrome patients
InterventionSjögren’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 typeOther
Primary outcome measureCaries at the coronal and root surface evaluated using the International Caries Detection and Assessment System (ICDAS) at 12 months and 24 months
Secondary outcome measuresCounts 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 study start date03/01/2009
Completion date30/10/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment11/06/2009
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Hong Kong

Study participating centre

Prince Philip Dental Hospital
Faculty of Dentistry
The University of Hong Kong
34 Hospital Road
Sai Ying Pun
-
Hong Kong

Sponsor information

Research Grants Council of Hong Kong
Research council

7/F., Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong
-
Hong Kong

ROR logo "ROR" https://ror.org/00djwmt25

Funders

Funder type

Research council

Research Grants Council, University Grants Committee
Private sector organisation / Universities (academic only)
Alternative name(s)
研究資助局, 研究資助局, 研究資助局, 研究資助局, 研究資助局
Location
Hong Kong

Results and Publications

Intention to publish date08/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planA manuscript has been submitted to be considered for publication
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/09/2016 Yes No

Editorial Notes

23/09/2016: Publication reference added.