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

University of Leeds

Status: Unknown

Conditions: Postoperative Sensitivity of Existing Dental Filling Materials

Treatments: Device: Fill-Up composite resin

Study type: Interventional

Funder types: Other

Identifiers

NCT03513692

IRAS project ID: 213486

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Fill-Up composite resin

Active Comparator group

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.

Treatment:

Device: Fill-Up composite resin

Conventional; composite

Active Comparator group

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.

Treatment:

Device: Fill-Up composite resin