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

Not Applicable

• Conditions: Postoperative Sensitivity of Existing Dental Filling Materials
• Interventions: Device: Fill-Up composite resin

• Registration Number: NCT03513692
• Lead Sponsor: University of Leeds

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fill-Up composite resin	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.
Conventional; composite	Fill-Up composite resin	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.

Primary Outcome Measures

Name	Time	Method
Post operative sensitivity	1 month	patient assessment by VAS

Trial Locations

Locations (1)

University of Leeds; 🇬🇧 Leeds, Yorkshire, United Kingdom