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
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
Scientific
Prosthodontics
Prince Philip Dental Hospital
34 Hospital Road
Sai Ying Pun
Hong Kong
-
Hong Kong
 ORCID ID |
0000-0003-3703-8232 |
|---|
Study information
| Study design | Randomized double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjögren’s syndrome patients |
| Study objectives | Quarterly 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) studied | 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 |
| Primary outcome measure | 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 study start date | 03/01/2009 |
| Completion date | 30/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/06/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
The University of Hong Kong
34 Hospital Road
Sai Ying Pun
-
Hong Kong
Sponsor information
Research council
7/F., Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong
-
Hong Kong
"ROR" |
https://ror.org/00djwmt25 |
|---|
Funders
Funder type
Research council
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 date | 08/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A 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.
