Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
26/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Brunton

ORCID ID

Contact details

Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 0113 3436182
p.a.brunton@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0644188383

Study information

Scientific title

Evidence-based prevention of dentine hypersensitivity: A randomized controlled trial to test three interventions

Acronym

Study hypothesis

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

Leeds East Ethics Committee (UK)

Study design

Randomised 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 the contact details below to request a patient information sheet

Condition

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 patient’s response to the intervention will be tested at follow up examinations.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Immediate reduction of dental hypersensitivity

Secondary outcome measures

Prolonged reduction in dental hypersensitivity

Overall trial start date

01/02/2009

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

75, 25 per group

Participant 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

Recruitment start date

01/02/2009

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Greater Manchester Primary Care RM&G Partnership (ReGroup) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Oral Dental Health Research Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23791771

Publication citations

Additional files

Editorial Notes

26/04/2016: Publication reference added