Restauration in SituNCT01411592
Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses
A study testing Multilink and Panavia 21 TC in people with Restauration in Situ and Final Loss of Restauration, run by University of Kiel.
Trial summary
The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restauration in Situ, Final Loss of Restauration, Debonded Restauration
- What is being tested?
- Multilink and Panavia 21 TC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- sufficient oral hygiene
- one caries free or almost caries free abutment tooth available
- sufficient space for the retainer wing available
- patients willingness to return at regular intervals for at least 5 years for evaluation
Who cannot join
- clinical symptoms of bruxism
- collision, full or semi-contact sports (Boxing, Karate)
- pregnant women
- untreated advanced periodontitis
About this study
Official title: Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System
The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.
The aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.
- Being tested
- Multilink, Panavia 21 TC
- Keywords
- All-Ceramic, Resin-bonded Fixed Dental Protheses, Single Retainer, Randomized Clinical Trial, Resin Bond, Bonding System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultilinkOther
Also called Multilink-Automix, Ivoclar Vivadent, Metal/Zirconia-Primer, Ivoclar Vivadent, A/B-Primer, Ivoclar Vivadent
After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer)
Panavia 21 TCOther
Also called Panavia 21 TC, Kuraray
After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer
| Study group | Role | What they receive |
|---|---|---|
| Multilink | Active comparator | RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer) Receives: Other: Multilink |
| Panavia 21 TC | Active comparator | RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer Receives: Other: Panavia 21 TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Loss of the Restauration
Measured: 5 years
Secondary outcomes (1)
Debonding of the RBFDP
Restoration was rebonded without any impairment of function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restauration in SituStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Martin Sasse, University of Kiel
- Investigators
- Matthias Kern, DDS, PhD, Study director, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411592
- Sponsor's protocol ID
- Ivoclar ZirCAD Adh.bruecken
- Status last verified
- Sep 2014
- First submitted
- 3 Aug 2011
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German.
PubMed 23930573
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System
- ClinicalTrials.gov ID
- NCT01411592
- Acronym / sponsor ID
- Ivoclar ZirCAD Adh.bruecken
- Keywords
- All-Ceramic, Resin-bonded Fixed Dental Protheses, Single Retainer, Randomized Clinical Trial, Resin Bond, Bonding System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.
The aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multilink | Active comparator | Other: MultilinkRBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer) |
| Panavia 21 TC | Active comparator | Other: Panavia 21 TCRBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- sufficient oral hygiene
- one caries free or almost caries free abutment tooth available
- sufficient space for the retainer wing available
- patients willingness to return at regular intervals for at least 5 years for evaluation
Key exclusion criteria (4 listed)
- clinical symptoms of bruxism
- collision, full or semi-contact sports (Boxing, Karate)
- pregnant women
- untreated advanced periodontitis
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 |
|---|---|---|
| MultilinkAlso: Multilink-Automix, Ivoclar Vivadent, Metal/Zirconia-Primer, Ivoclar Vivadent, A/B-Primer, Ivoclar VivadentAfter air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer) | Other | Multilink |
| Panavia 21 TCAlso: Panavia 21 TC, KurarayAfter air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer | Other | Panavia 21 TC |
Primary outcome
Final Loss of the Restauration
Time frame: 5 years
1 secondary outcome
Debonding of the RBFDP
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23930573Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German.
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.
Matthias Kern, DDS, PhD study director
University of Kiel
Questions about this trial
What is this clinical trial studying?
A study testing Multilink and Panavia 21 TC in people with Restauration in Situ and Final Loss of Restauration, run by University of Kiel.
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 4 inclusion and 4 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 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Final Loss of the Restauration (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411592, which also lists 1 linked publication.
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 11 Sep 2014.