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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Sensitivity of Existing Dental Filling Materials

Intervention / Treatment
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* Device: Fill-Up composite resin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fill-Up composite resin<br>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<br>* 2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite<br>* Other names: conventional composite resin;|
| Active Comparator: Conventional; composite<br>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<br>* 2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite<br>* Other names: conventional composite resin;|

What is the study measuring?
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Primary Outcome Measures

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