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

NCT ID: NCT03513692

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

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.

Detailed Description

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Conditions

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Postoperative Sensitivity of Existing Dental Filling Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fill-Up composite resin

Intervention Type DEVICE

2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite

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.

Group Type ACTIVE_COMPARATOR

Fill-Up composite resin

Intervention Type DEVICE

2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite

Interventions

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Fill-Up composite resin

2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite

Intervention Type DEVICE

Other Intervention Names

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conventional composite resin

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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T Paul Hyde

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Leeds

Leeds, Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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T P hyde, PhD BChD

Role: CONTACT

+44 (0)1133438515

Facility Contacts

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T P Hyde, PhD BChD

Role: primary

+44 (0)1133438515

Nihad Vaid, BDS

Role: backup

Other Identifiers

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IRAS project ID: 213486

Identifier Type: -

Identifier Source: org_study_id

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