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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Sensitivity of Existing Dental Filling Materials
• Intervention / Treatment: Device: Fill-Up composite resin

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: T P Hyde, PhD BChD; Phone Number: +44 (0)1133438515; Email: t.p.hyde@leeds.ac.uk

Study Locations

• United Kingdom
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS2 9LU
      • Recruiting
      • University of Leeds
      • Contact: T P Hyde, PhD BChD; Phone Number: +44 (0)1133438515; Email: t.p.hyde@leeds.ac.uk
      • Contact: Nihad Vaid, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fill-Up composite resin; 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.	Device: Fill-Up composite resin; 2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite; Other Names: conventional composite resin
Active Comparator: Conventional; composite; 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.	Device: Fill-Up composite resin; 2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite; Other Names: conventional composite resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative sensitivity	patient assessment by VAS	1 month

Collaborators and Investigators

• Sponsor: University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: IRAS project ID: 213486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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