Condition category
Oral Health
Date applied
08/01/2013
Date assigned
19/03/2013
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A type of material called an amalgam used to be the filling material of choice for dental fillings on back teeth. Nowadays many patients want something that looks nicer and composite resin has become the material of choice. It provides improved aesthetics, reduced temperature conductivity and it is mercury free. It allows bonding to the tooth structure which reduces leakage. There are aspects of the properties of composite resin that could be improved: shrinkage when it sets, tooth more likely to be sensitive after filling, poorer wear resistance than amalgam, can be difficult to manipulate.
There are ways of improving these properties such as lowering the viscosity of the composite via preheating. This is a recognised technique and there are many in vitro studies which demonstrate improvements. There are however no scientific papers which compare the post operative sensitivity of a pre-warmed composite with a room temperature composite. This is the aim of this study.

Who can participate?
Patients who attend the General Dental Practice of Mr Iain Campbell in Scunthrope, Yorkshire, UK. The sdudy will aim to recruit two groups of 60 patients each.

What does the study involve?
Patients will be randomly allocated to one of two groups: treatment involving a a pre-warmed composite or a treatment involving a composite at room temperature.
When a patient has had a routine dental check-up and a one or two surface filling is required, the patient will be asked if they would like to take part in the study. The filling appointment will be made two weeks later. On average a one or two surface filling will take 30 to 40 minutes. At the filling appointment the patient will again be asked if they are happy to take part in the study and their consent form countersigned by the student investigator. The patient will have to fill in a pre treatment sensitivity test using an approach called a visual analogue scale (VAS). The patient will be given three more VAS sheets to fill in at home the day after, the week after and two weeks after. The dental surgery assistant will also telephone the patient to remind them re the VAS forms and check that all is well. The patient will be asked to return a month later to check the filling (this appointment may coincide with further treatment) fill in a final VAS sheet and bring all their VAS sheets back.

What are the possible benefits and risks of participating?
There will be no direct benefit to patients but with the information obtained from the results may tell us if warming the dental material leads to reduced sensitivity following a dental filling. There will be no financial benefits and all normal fees will apply.

Where is the study run from?
The University of Leeds will oversee the research and the study will take place at the General Dental Practice of Mr Iain Campbell in Scunthrope, Yorkshire, UK.

When is the study starting and how long is it expected to run for?
It is anticipated the study will run from January to December 2013.

Who is funding the study?
The study is part of a Master’s research project. The University of Leeds will provide resources for the research and the student investigator will provide clinical resources for the study.

Who is the main contact?
Dr T Paul Hyde
t.p.hyde@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr T Paul Hyde

ORCID ID

http://orcid.org/0000-0002-5324-2842

Contact details

Restorative Dentistry
Leeds Dental Institute
Clarendon Way
University of Leeds
Leeds
LS2 9LU
United Kingdom
-
t.p.hyde@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 6 30.07.2012

Study information

Scientific title

A study to determine if the process of warming composite resin restorative material prior to placement of a restoration leads to any changes in post operative sensitivity: a parallel sided randomised controlled trial

Acronym

Study hypothesis

The null hypothesis is that there is no difference in post-operative sensitivity between composite warmed to 39degreeC at placement and room temperature composite.
The alternative hypothesis is that there is a difference in post operative sensitivity between the room temperature and the warmed composite.

Ethics approval

University of Leeds Dental Research Ethics Committee (DREC)

Study design

Parallel sided randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Restorative dentistry

Intervention

The interventions are the routine placement of composite restorative material in a prepared tooth cavity (a dental ‘filling’). For the control this is with the filling material at room temperature (i.e. normal practice) and for the parallel experimental side of the trial it is with composite warmed to 39 degrees.

When a patient has had a routine dental check-up and a one or two surface filling is required the patient will be asked if they would like to take part in the study. The filling appointment will be made 2 weeks later, on average a one or two surface filling will take 30 to 40 minutes. At the filling appointment the patient will again be asked if they are happy to take part in the study and their consent form countersigned by the student investigator. A pre treatment sensitivity VAS scale will be scored by the patient. The patient will be given 3 more VAS sheets to take home to score the day after, the week after and 2 weeks after. Their permission will be sought for the dental surgery assistant of the student investigator to telephone the patient to remind them and check all is well. The patient will be asked to return a month later to check the filling (this appointment may coincide with further treatment) fill in a final VAS sheet and bring their VAS sheets back.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

VAS assessment 24 hours after treatment

Secondary outcome measures

VAS assessment 7 days, 14 days and 1 month after treatment

Overall trial start date

08/01/2013

Overall trial end date

08/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient is over 18
2. Patient is under 70
3. Either sex
3. Patient is capable of informed consent
4. The tooth responds to sensitivity testing (‘vitality test’ with an electric pulp tester)
5. The cavity to be restored is a one or two surface cavity
6. The cavity is suitable for composite restoration and the patient prefers composite to amalgam

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. The tooth does not respond to an electric pulp test
2. The patient is incapable of giving informed consent
3. The patient is a child under 18
4. The patient is unable to return the Visual Analogue Scale (VAS) assessment sheets at the appropriate time
5. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)
6. The tooth to be filled is an abutment tooth for a removable prosthesis
7. The tooth to be filled has undergone orthodontic treatment within the last 3 months
8. The tooth to be filled has had periodontal surgery within the last 3 months

Recruitment start date

08/01/2013

Recruitment end date

08/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Restorative Dentistry
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty of Medicine and Health
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

University/education

Funder name

University of Leeds (UK) - Master's program

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination via conference presentation (at BSODR conference 2015) and on-going publication in a clinical journal.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/07/2016: Verified study information with principal investigator. Added ORCID ID, publication and data sharing plans. 29/06/2016: No publications found, verifying study status with principal investigator