Evidence-based prevention of dentine hypersensitivity: A randomized controlled trial to test three interventions
| ISRCTN | ISRCTN80600298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80600298 |
| Protocol serial number | N0644188383 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Greater Manchester Primary Care RM&G Partnership (ReGroup) (UK), Oral Dental Health Research Trust, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Immediate reduction of dental hypersensitivity |
| Key secondary outcome measure(s) |
Prolonged reduction in dental hypersensitivity |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 75 |
| 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
- United Kingdom
- England
Study participating centre
Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/04/2016: Publication reference added
