A Randomised Controlled Trial to Compare Post-operative Sensitivity of Restorations Completed With Fill-Up, a Dual Curing Composite and Conventional Composite Resin

University of Leeds1 site in 1 country34 target enrollmentJanuary 1, 2017

ConditionsPostoperative Sensitivity of Existing Dental Filling Materials

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Sensitivity of Existing Dental Filling Materials
Sponsor: University of Leeds
Enrollment: 34
Locations: 1
Primary Endpoint: Post operative sensitivity
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. The dental filling materials will be used according to manufacturer's instructions and within the existing CE marked licence. We are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use.

Registry

clinicaltrials.gov

Start Date

January 1, 2017

End Date

December 1, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Leeds

Responsible Party

Principal Investigator

T Paul Hyde

Clinical Associate Professor

University of Leeds

Eligibility Criteria

Inclusion Criteria

•Patient is over 18
•Patient is under 70
•Patient is capable of informed consent
•The tooth responds to sensitivity testing ('vitality test' with an electric pulp tester)
•The cavity is suitable for composite restoration
•The patient prefers composite to amalgam.
•The restoration required involves 2 or more surfaces of the tooth

Exclusion Criteria

•The tooth does not respond to an electric pulp test
•The patient is suffering dental pain at the time of consent
•The patient is currently taking long term analgesics
•The patient is incapable of giving informed consent
•The patient is a child under 18
•The patient is unable to return the VAS assessment sheets at the appropriate time
•The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)