Postoperative Sensitivity of Existing Dental Filling MaterialsNCT03513692
A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
A study testing Fill-Up composite resin in people with Postoperative Sensitivity of Existing Dental Filling Materials, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sensitivity of Existing Dental Filling Materials
- What is being tested?
- Fill-Up composite resin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leeds
Leeds, Yorkshire, LS2 9LU
T P Hyde, PhD BChD, +44 (0)1133438515, t.p.hyde@leeds.ac.uk
Nihad Vaid, BDS
About this study
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
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.
- Being tested
- Fill-Up composite resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill-Up composite resinDevice
Also called conventional composite resin
2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite
| Study group | Role | What they receive |
|---|---|---|
| Fill-Up composite resin | Active comparator | 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. Receives: Device: Fill-Up composite resin |
| Conventional; composite | Active comparator | 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. Receives: Device: Fill-Up composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative sensitivity
patient assessment by VAS
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jan 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sensitivity of Existing Dental Filling MaterialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, T Paul Hyde, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513692
- Sponsor's protocol ID
- IRAS project ID: 213486
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03513692
- Acronym / sponsor ID
- IRAS project ID: 213486
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fill-Up composite resin | Active comparator | Device: Fill-Up composite resinIn 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. |
| Conventional; composite | Active comparator | Device: Fill-Up composite resinIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fill-Up composite resinAlso: conventional composite resin2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite | Device | Conventional; composite, Fill-Up composite resin |
Primary outcome
Post operative sensitivity
Time frame: 1 month
patient assessment by VAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fill-Up composite resin in people with Postoperative Sensitivity of Existing Dental Filling Materials, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact T P hyde, PhD BChD (+44 (0)1133438515, t.p.hyde@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative sensitivity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.