Evidence-based prevention of dentine hypersensitivity: A randomized controlled trial to test three interventions
| ISRCTN | ISRCTN80600298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80600298 |
| Secondary identifying numbers | N0644188383 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 26/04/2016
- 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
Not provided at time of registration
Contact information
Prof Paul Brunton
Scientific
Scientific
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 0113 3436182 |
|---|---|
| p.a.brunton@leeds.ac.uk |
Study information
| Study design | Randomised 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 the contact details below to request a patient information sheet |
| Scientific title | Evidence-based prevention of dentine hypersensitivity: A randomized controlled trial to test three interventions |
| Study objectives | 1. Despite sensitive teeth being a common problem there is no evidence base for the treatments used with sensitivity returning soon after treatment. Furthermore, the amount of clinical time devoted to the management of hypersensitive teeth is significant. Therefore, an intervention, which is evidence based, simple and conservative, yet produces lasting relief would be desirable. This study investigates how effective typical treatments are at providing immediate relief for the pain of sensitive teeth. 2. To determine if these treatments are effective over a period of six months. |
| Ethics approval(s) | Leeds East Ethics Committee (UK) |
| Health condition(s) or problem(s) studied | Oral Health: Dentine hypersensitivity |
| Intervention | The three test interventions will be: 1. No treatment 2. Application of a dentine bonding agent 3. Use of a desensitising toothpaste In essence three groups of 25 subjects will be included in the study. As part of their routine examination patients will be screened for sensitive teeth. Having had chance to read the patient information leaflet they will be asked to sign a consent form if they are happy to be included in the study. They will then be randomly allocated to one of the three groups and they will receive one of the three interventions of interest. With the exception of the control these interventions are all approved medical devices that will only be used according to their directions for use. The patients response to the intervention will be tested at follow up examinations. |
| Intervention type | Other |
| Primary outcome measure | Immediate reduction of dental hypersensitivity |
| Secondary outcome measures | Prolonged reduction in dental hypersensitivity |
| Overall study start date | 01/02/2009 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 75, 25 per group |
| Key inclusion criteria | 75 patients with at least one tooth sensitive to hot, cold and sweet stimuli, which does not require any operative treatment (i.e. fillings) will be invited to participate in the study. As part of their routine examination patients will be screened for sensitive teeth according to our protocol. Having had chance to read the patient information leaflet they will then be asked to sign a consent form if they are happy to be included in the study. Inclusion criteria: 1. At least one sensitive tooth. To be eligible subjects will be required to have at least one test tooth sensitive to an evaporative stimulus greater than 40 mm and less than 80 mm on the 100mm visual analogue scale (VAS). 2. Sensitive lesion not requiring restoration 3. Good oral hygiene and gingival health |
| Key exclusion criteria | 1. Under 18 years old 2. Sensitivity resulting from a lesion requiring any form of restoration 3. Sensitivity arising from heavily restored teeth 4. Poor oral hygiene or gingival health |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Greater Manchester Primary Care RM&G Partnership (ReGroup) (UK)
No information available
Oral Dental Health Research Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | Yes | No |
Editorial Notes
26/04/2016: Publication reference added
