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

Postoperative Sensitivity of Existing Dental Filling Materials Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513692
• Other study ID #: IRAS project ID: 213486
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2019
• Source: University of Leeds
• Contact: T P hyde, PhD BChD
• Phone: +44 (0)1133438515
• Email: t.p.hyde[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypersensitivity
• Postoperative Sensitivity of Existing Dental Filling Materials

Intervention

Device:
• Fill-Up composite resin
2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative sensitivity	patient assessment by VAS	1 month