RCT of Post-op sensitivity; Fill-Up vs conventional composite
Research type
Research Study
Full title
A randomised controlled trial to compare post-operative sensitivity of restorations completed with Fill-Up, a dual curing composite and conventional composite resin.
IRAS ID
213486
Contact name
T Paul Hyde
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Following a dental filling with conventional composite resin material, post-operative sensitivity of the tooth can occur. This sensitivity can be caused by a number of issues. The polymerization shrinkage of composite has been shown to lead to stress and distortion of the cusps of the tooth which in turn leads to postoperative sensitivity. Alternatively the polymerisation shrinkage can cause the composite to shrink away from the cavity walls leaving a gap which leads to micro-leakage and causes post-operative sensitivity.
Additional causes of post-operative sensitivity are associated with operator related errors. Imprecise or inappropriate incremental build-up of the layers of composite can occur. If the layers are too deep or the layers are inadequately light-cured this leads to the under-surface of the restoration being uncured. Uncured composite can be a direct irritant or can allow leakage; both result in post-operative sensitivity.
Recently a dual-curing bulk composite Fill-Up, has been introduced. Fill-Up is said to allow a thorough, slower curing process, thus ensuring the material is fully set throughout the cavity whilst also minimizing shrinkage stress. These benefits should reduce the risk of post-operative sensitivity.
This research aims to use a parallel sided Randomized Controlled Trial protocol to determine whether the use of Fill-Up, a dual-curing bulk composite, leads to a change in post-operative sensitivity when compared to restoring a tooth with conventional composite resin.
All restorative materials used within this study will be CE marked materials, licensed for use in the UK and used as designated for clinical use. The research will be carried out within the Dental Translational and Clinical Research Unit (DenTCRU) of the University of Leeds situated at the Leeds Dental Hospital. Participants will be over 18 years of age, capable of informed consent and require a restoration of 2 or more surfaces of a molar tooth.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0416
Date of REC Opinion
27 Oct 2016
REC opinion
Further Information Favourable Opinion