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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03513692

Enrollment

Registered

2018-05-01

Start date

2017-01-01

Completion date

2019-12-01

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sensitivity of Existing Dental Filling Materials

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.

Interventions

DEVICEFill-Up composite resin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Post operative sensitivity	1 month	patient assessment by VAS

Countries

United Kingdom

Contacts

Primary ContactT P hyde, PhD BChD

t.p.hyde@leeds.ac.uk+44 (0)1133438515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026