Failing Dental Composite RestorationsRVRNCT02046109
Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced
A study testing Repair and Replace in people with Failing Dental Composite Restorations, run by Dalhousie University at 1 site in Canada.
Trial summary
The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced. It is hypothesized that both treatment will have comparable success rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failing Dental Composite Restorations
- What is being tested?
- Repair and Replace
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the Dalhousie University Dental Clinic who are:
- Age 18 and over
- Capable of providing informed consent
- Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
- Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.
Who cannot join
- Patients with contra-indications for regular dental treatment based on their medical history
- Teeth with active caries
- Teeth with multiple overlapping composite restorations
- Patients with uncontrolled periodontal disease
- Restorations smaller than 3mm diameter
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dalhousie University Faculty of Dentistry
Halifax, Nova Scotia, B3H 4R2
About this study
Official title: Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial
The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.
It is hypothesized that both treatment will have comparable success rate.
Read the detailed description
This study is a single-blind randomized non-inferiority trial using parallel groups.
Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.
The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.
- Conditions
- Failing Dental Composite Restorations
- Being tested
- Repair, Replace
- Keywords
- Repair, Replace, Composite, restoration, failing dental restoration, filling, dental, dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepairProcedure or surgery
Also called Scotchbond Universal, Filtek Supreme
ReplaceProcedure or surgery
Also called Scotchbond Universal, Filtek Supreme
| Study group | Role | What they receive |
|---|---|---|
| Repair | Experimental | Subjects in the Repair group will be given a local anesthetic only if required (i.e. for restorations extending gingivally or on exposed dentin surface) as per usual clinical protocol. The existing restoration will not be removed. The surface of the existing restoration will be roughened with a Brasseler 8856 bur without extending to the surrounding enamel (except is the defect being repaired is adjacent to enamel). No accessory groves/pits for retention will be prepared. To repair the restoration, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions. Receives: Procedure: Repair |
| Replace | Active comparator | Subjects in the Replace group will be given local anesthetic (an injection of 2% lidocaine with 1:100 000 epinephrine). The type of injection and dosage of anesthetics will be dependent on the tooth being treated, and will follow the usual protocol used in the Dalhousie Dentistry undergraduate clinics. The existing composite restoration will then be removed and the peripheral enamel beveled if not already beveled. To restore the tooth, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions. Receives: Procedure: Replace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The primary outcome will be the success of the restoration. This will be assessed using the modified U.S. Public Health Service (USPHS) criteria as first described by Cvar and Ryge (1971) and adapted by Wilson et al (2002).
Measured: 12-month
Secondary outcomes (1)
Survival
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Because of logistic problems, we could not recruit any patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failing Dental Composite RestorationsStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre-Luc Michaud, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046109
- Sponsor's protocol ID
- DalDent-2014-01
- Acronym
- RVR
- Status last verified
- Jun 2016
- First submitted
- 23 Jan 2014
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacement Versus Repair of Composite Restorations, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02046109
- Acronym / sponsor ID
- RVR / DalDent-2014-01
- Conditions
- Failing Dental Composite Restorations
- Keywords
- Repair, Replace, Composite, restoration, failing dental restoration, filling, dental, dentistry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of logistic problems, we could not recruit any patient.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jan 2014 (estimated)
- 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 objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.
It is hypothesized that both treatment will have comparable success rate.
Detailed description
This study is a single-blind randomized non-inferiority trial using parallel groups.
Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.
The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair | Experimental | Procedure: RepairSubjects in the Repair group will be given a local anesthetic only if required (i.e. for restorations extending gingivally or on exposed dentin surface) as per usual clinical protocol. The existing restoration will not be removed. The surface of the existing restoration will be roughened with a Brasseler 8856 bur without extending to the surrounding enamel (except is the defect being repaired is adjacent to enamel). No accessory groves/pits for retention will be prepared. To repair the restoration, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions. |
| Replace | Active comparator | Procedure: ReplaceSubjects in the Replace group will be given local anesthetic (an injection of 2% lidocaine with 1:100 000 epinephrine). The type of injection and dosage of anesthetics will be dependent on the tooth being treated, and will follow the usual protocol used in the Dalhousie Dentistry undergraduate clinics. The existing composite restoration will then be removed and the peripheral enamel beveled if not already beveled. To restore the tooth, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of the Dalhousie University Dental Clinic who are:
- Age 18 and over
- Capable of providing informed consent
- Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
- Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.
Key exclusion criteria (5 listed)
- Patients with contra-indications for regular dental treatment based on their medical history
- Teeth with active caries
- Teeth with multiple overlapping composite restorations
- Patients with uncontrolled periodontal disease
- Restorations smaller than 3mm diameter
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 |
|---|---|---|
| RepairAlso: Scotchbond Universal, Filtek Supreme | Procedure or surgery | Repair |
| ReplaceAlso: Scotchbond Universal, Filtek Supreme | Procedure or surgery | Replace |
Primary outcome
Success rate
Time frame: 12-month
The primary outcome will be the success of the restoration. This will be assessed using the modified U.S. Public Health Service (USPHS) criteria as first described by Cvar and Ryge (1971) and adapted by Wilson et al (2002).
1 secondary outcome
Survival
Time frame: 12-month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Dalhousie University Faculty of Dentistry Web SiteLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair and Replace in people with Failing Dental Composite Restorations, run by Dalhousie University at 1 site in Canada.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Jun 2016. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 12-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 22 Jun 2016.