Back to resultsA RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Primary Purpose
Postoperative Sensitivity of Existing Dental Filling Materials
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fill-Up composite resin
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Sensitivity of Existing Dental Filling Materials
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)
Sites / Locations
- University of LeedsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fill-Up composite resin
Conventional; composite
Arm Description
In this arm of the study, participants will have the dental restoration completed with "FillUp" from Coltene, a composite resin a CE marked and licensed restorative material.
In this arm of the study, participants will have the dental restoration completed with a conventional composite resin using a CE marked and licensed restorative material.
Outcomes
Primary Outcome Measures
Post operative sensitivity
patient assessment by VAS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03513692
Brief Title
A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Official Title
A Randomised Controlled Trial to Compare Post-operative Sensitivity of Restorations Completed With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sensitivity of Existing Dental Filling Materials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fill-Up composite resin
Arm Type
Active Comparator
Arm Description
In this arm of the study, participants will have the dental restoration completed with "FillUp" from Coltene, a composite resin a CE marked and licensed restorative material.
Arm Title
Conventional; composite
Arm Type
Active Comparator
Arm Description
In this arm of the study, participants will have the dental restoration completed with a conventional composite resin using a CE marked and licensed restorative material.
Intervention Type
Device
Intervention Name(s)
Fill-Up composite resin
Other Intervention Name(s)
conventional composite resin
Intervention Description
2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite
Primary Outcome Measure Information:
Title
Post operative sensitivity
Description
patient assessment by VAS
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
T P hyde, PhD BChD
Phone
+44 (0)1133438515
Email
t.p.hyde@leeds.ac.uk
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS2 9LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T P Hyde, PhD BChD
Phone
+44 (0)1133438515
Email
t.p.hyde@leeds.ac.uk
First Name & Middle Initial & Last Name & Degree
Nihad Vaid, BDS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
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