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21 March 2013
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN76727312 |
| DOI | 10.1186/ISRCTN76727312 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public 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 |
| 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 | N/A |
| Serial number at source | Version 6 30.07.2012 |
| 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. |
| Lay 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 |
| Ethics approval | University of Leeds Dental Research Ethics Committee (DREC) |
| Study design | Parallel sided randomised controlled clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Restorative dentistry |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 08/01/2013 |
| Anticipated end date | 08/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 120 |
| Interventions |
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. |
| Primary outcome measure(s) | VAS assessment 24 hours after treatment |
| Secondary outcome measure(s) | VAS assessment 7 days, 14 days and 1 month after treatment |
| Sources of funding | University of Leeds (UK) - Master's program |
| Trial website | |
| Publications | |
| Contact name | Dr T Paul Hyde |
| Address |
Restorative Dentistry
Leeds Dental Institute Clarendon Way University of Leeds |
| City/town | Leeds |
| Zip/Postcode | LS2 9LU |
| Country | United Kingdom |
| t.p.hyde@leeds.ac.uk | |
| Sponsor | University of Leeds (UK) |
| Address |
Faculty of Medicine and Health
Level 10, Worsley Building Clarendon Way |
| City/town | Leeds |
| Zip/Postcode | LS2 9JT |
| Country | United Kingdom |
| Sponsor website: | http://www.leeds.ac.uk/ |
| Date applied | 08/01/2013 |
| Last edited | 19/03/2013 |
| Date ISRCTN assigned | 19/03/2013 |
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