Dental Restoration Failure of Marginal IntegrityNCT03645551
Clinical Longevity of Ceramic Laminate Veneers
An observational study of Dental Restoration Failure of Marginal Integrity, run by University Medical Center Groningen.
Trial summary
Rationale: Survival rates of teeth with laminate veneers were reported to have more marginal caries and discoloration when existing restorations are present. However in these studies no conditioning of the existing restorations was performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- checkup, no test
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is an evaluative prospective study where over 450 laminate veneers were made in 110 patients. All patients will be asked to enrol in the study. Probably 90% will come to an evaluation appointment when asked to enrol. 90% seems very high but all patients were formerly patients when dr. Gresnigt was still working in a private general dentistry office. So reasonably 400 laminate veneers with 100 patients will be expected to be evaluated.
Who may be able to join
- All patients treated with laminate veneers by dr. Gresnigt
- at least 18 years old
- able to read and sign the informed consent document
- physically and psychologically able come for an evaluation as outlined by the investigators.
Who cannot join
- People not able to return or not willing to come for an evaluation
- People died
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Longevity of Ceramic Laminate Veneers Bonded to Teeth With and Without Existing Composite Restorations up to 10 Years
Rationale: Survival rates of teeth with laminate veneers were reported to have more marginal caries and discoloration when existing restorations are present. However in these studies no conditioning of the existing restorations was performed.
Objective: This study evaluate the survival rate of ceramic laminate veneers bonded to teeth with and without existing composite restorations Study design: Prospectief Cohort research Study population: the participants received laminate veneers and older then 18 years.
Read more
Intervention (if applicable): The participants received laminate veneers in the past. No intervention.
Main study parameters/endpoints: Survival and success of laminate veneers with existing restorations: Survival (no loss of laminate veneer during follow up time), Success was measured using USPHS health criteria.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants are asked to come for a check-up of their restorations, the investigators will evaluate the laminate veneers by sight and take some light photo's and a patient questionnaire will be given.
Read the detailed description
The use of ceramic laminate veneers as opposed to metal-ceramic or all-ceramic full-coverage crowns is a minimal invasive treatment option in reconstructive dentistry. Since their retention relies solely on adhesion, durable adhesion of resin luting cements to both the enamel/dentin and the cementation surface of the ceramic is crucial. Luting cements used in conjunction with phosphoric acid etching followed by adhesive application on enamel show reliable adhesion with mean bond strengths up to 40 MPa. Also, etching the intaglio of glass ceramic veneers with hydrofluoric acid followed by silane coupling agent application delivers bond strength values similar to or higher than to enamel. Even after long-term water storage and thermocycling aging conditions, promising results were reported with resin-ceramic adhesion. Ceramic laminates are indicated not only to restore malformed, malpositioned, or discolored teeth where mainly the substrate is the enamel and/or dentin but also in situations where resin composite restorations are present on the tooth to be restored. In case of secondary caries, severe marginal or surface changes, it may be necessary to remove such restorations. On the other hand, degradation of polymers in the aggressive oral environment may decrease the free radicals available on the resin surface that may eventually decrease the adhesion of resin cements to such composites. However, limited information is available on the survival of ceramic laminates on such existing composite restorations where mainly fractures and marginal defects were reported. Defects were especially noticed at the locations where the existing fillings were present. In fact, today, advances in surface conditioning methods and adhesion promoters enable durable composite-composite adhesion. Among numerous other methods, several studies reported increased composite- composite bond strengths after conditioning the composites with alumina or alumina-coated silica particles followed by silanization. The process of silanization promotes the wettability of the substrates and further reacts with the glass particles present on the composite surface forming covalent bonds. Composite- composite bond strength simulating aging after silica coating and silanization was reported to deliver significantly higher bond strengths (46-52 MPa) than conditioning the composite substrate with phosphoric acid and adhesive resin application only (16-25 MPa). Unfortunately, the previous clinical studies did not report application of any surface conditioning method prior to cementation of ceramic laminates. In clinical practice, the clinical dilemma is whether or not to remove the existing composite restorations with no indications of caries or acceptable surface degradation that could be refinished and repolished. Alternatively, full-coverage crowns are indicated on teeth with large composite restorations that require more tissue removal yielding to preparations in dentin that is a substrate less favorable to bond onto than enamel. The objective of this prospective clinical study is to evaluate the performance of ceramic laminate veneers bonded onto either intact teeth or to teeth with existing composite restorations with no indications of caries, ditching, or marginal staining. The null hypothesis tested is that the presence of existing composite restorations would not decrease the survival rate of ceramic laminate veneers compared to those bonded onto intact teeth.
- Being tested
- checkup, no test
- Keywords
- dentistry, laminate veneer, existing restoration, survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
checkup, no testDiagnostic test
In this study we would like to examine if existing restorations already applied in teeth which we treated with laminate veneers had an effect. We will evaluate the laminate veneers by sight and take pictures and use a questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Restorations which survived when applied on the tooth till the last follow up. (survival)
Caries, debonding, chipping, and fracture are considered as absolute failures. Due to these factors the restorations will be lost and a new one has to be made, that is why these scores are survival and main endpoints.
Measured: june 2007- september 2018
Secondary outcomes (1)
Succes
Both observers evaluate the restorations independently, according to the modified United States Public Health Service (USPHS) criteria on Marginal Adaptation, Color match, Marginal discoloration, Surface roughness, Fracture of the restoration, Fracture of the tooth, wear of the restoration, wear of the antagonist, Caries, Postoperative sensitivity. Patient satisfaction. Above scores are not indications for removal of the restoration but sometimes can be a deterioration of the restoration itself. So the esthetic outcome can be a little less but the survival is still good.
Measured: june 2007 - september 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study startMay 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gresnigt, University Medical Center Groningen
- Investigators
- Marco Cune, Prof, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645551
- Sponsor's protocol ID
- Gresnigt
- Status last verified
- Apr 2019
- First submitted
- 21 Aug 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will focus on laminate veneers bonded to teeth with and without composite restorations. And also will be looked at preparations were more than 50% of dentin was exposed if an immediate dentin sealing would have an benefit.
Publications
Peumans M, De Munck J, Fieuws S, Lambrechts P, Vanherle G, Van Meerbeek B. A prospective ten-year clinical trial of porcelain veneers. J Adhes Dent. 2004 Spring;6(1):65-76.
PubMed 15119590Gresnigt MMM, Ozcan M, Carvalho M, Lazari P, Cune MS, Razavi P, Magne P. Effect of luting agent on the load to failure and accelerated-fatigue resistance of lithium disilicate laminate veneers. Dent Mater. 2017 Dec;33(12):1392-1401. doi: 10.1016/j.dental.2017.09.010. Epub 2017 Nov 1.
PubMed 29079354Gresnigt MM, Cune MS, de Roos JG, Ozcan M. Effect of immediate and delayed dentin sealing on the fracture strength, failure type and Weilbull characteristics of lithiumdisilicate laminate veneers. Dent Mater. 2016 Apr;32(4):e73-81. doi: 10.1016/j.dental.2016.01.001. Epub 2016 Feb 5.
PubMed 26856454Gresnigt MM, Kalk W, Ozcan M. Randomized clinical trial of indirect resin composite and ceramic veneers: up to 3-year follow-up. J Adhes Dent. 2013 Apr;15(2):181-90. doi: 10.3290/j.jad.a28883.
PubMed 23534025Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
PubMed 22821429Gresnigt M, Ozcan M, Kalk W. Esthetic rehabilitation of worn anterior teeth with thin porcelain laminate veneers. Eur J Esthet Dent. 2011 Autumn;6(3):298-313.
PubMed 21876866Gresnigt MM, Ozcan M, Kalk W, Galhano G. Effect of static and cyclic loading on ceramic laminate veneers adhered to teeth with and without aged composite restorations. J Adhes Dent. 2011 Dec;13(6):569-77. doi: 10.3290/j.jad.a21742.
PubMed 21734979Gresnigt MMM, Cune MS, Schuitemaker J, van der Made SAM, Meisberger EW, Magne P, Ozcan M. Performance of ceramic laminate veneers with immediate dentine sealing: An 11 year prospective clinical trial. Dent Mater. 2019 Jul;35(7):1042-1052. doi: 10.1016/j.dental.2019.04.008. Epub 2019 May 10.
PubMed 31084936
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
- Clinical Longevity of Ceramic Laminate Veneers Bonded to Teeth With and Without Existing Composite Restorations up to 10 Years
- ClinicalTrials.gov ID
- NCT03645551
- Acronym / sponsor ID
- Gresnigt
- Keywords
- dentistry, laminate veneer, existing restoration, survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Aug 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.
Rationale: Survival rates of teeth with laminate veneers were reported to have more marginal caries and discoloration when existing restorations are present. However in these studies no conditioning of the existing restorations was performed.
Objective: This study evaluate the survival rate of ceramic laminate veneers bonded to teeth with and without existing composite restorations Study design: Prospectief Cohort research Study population: the participants received laminate veneers and older then 18 years.
Intervention (if applicable): The participants received laminate veneers in the past. No intervention.
Main study parameters/endpoints: Survival and success of laminate veneers with existing restorations: Survival (no loss of laminate veneer during follow up time), Success was measured using USPHS health criteria.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants are asked to come for a check-up of their restorations, the investigators will evaluate the laminate veneers by sight and take some light photo's and a patient questionnaire will be given.
Detailed description
The use of ceramic laminate veneers as opposed to metal-ceramic or all-ceramic full-coverage crowns is a minimal invasive treatment option in reconstructive dentistry. Since their retention relies solely on adhesion, durable adhesion of resin luting cements to both the enamel/dentin and the cementation surface of the ceramic is crucial. Luting cements used in conjunction with phosphoric acid etching followed by adhesive application on enamel show reliable adhesion with mean bond strengths up to 40 MPa. Also, etching the intaglio of glass ceramic veneers with hydrofluoric acid followed by silane coupling agent application delivers bond strength values similar to or higher than to enamel. Even after long-term water storage and thermocycling aging conditions, promising results were reported with resin-ceramic adhesion. Ceramic laminates are indicated not only to restore malformed, malpositioned, or discolored teeth where mainly the substrate is the enamel and/or dentin but also in situations where resin composite restorations are present on the tooth to be restored. In case of secondary caries, severe marginal or surface changes, it may be necessary to remove such restorations. On the other hand, degradation of polymers in the aggressive oral environment may decrease the free radicals available on the resin surface that may eventually decrease the adhesion of resin cements to such composites. However, limited information is available on the survival of ceramic laminates on such existing composite restorations where mainly fractures and marginal defects were reported. Defects were especially noticed at the locations where the existing fillings were present. In fact, today, advances in surface conditioning methods and adhesion promoters enable durable composite-composite adhesion. Among numerous other methods, several studies reported increased composite- composite bond strengths after conditioning the composites with alumina or alumina-coated silica particles followed by silanization. The process of silanization promotes the wettability of the substrates and further reacts with the glass particles present on the composite surface forming covalent bonds. Composite- composite bond strength simulating aging after silica coating and silanization was reported to deliver significantly higher bond strengths (46-52 MPa) than conditioning the composite substrate with phosphoric acid and adhesive resin application only (16-25 MPa). Unfortunately, the previous clinical studies did not report application of any surface conditioning method prior to cementation of ceramic laminates. In clinical practice, the clinical dilemma is whether or not to remove the existing composite restorations with no indications of caries or acceptable surface degradation that could be refinished and repolished. Alternatively, full-coverage crowns are indicated on teeth with large composite restorations that require more tissue removal yielding to preparations in dentin that is a substrate less favorable to bond onto than enamel. The objective of this prospective clinical study is to evaluate the performance of ceramic laminate veneers bonded onto either intact teeth or to teeth with existing composite restorations with no indications of caries, ditching, or marginal staining. The null hypothesis tested is that the presence of existing composite restorations would not decrease the survival rate of ceramic laminate veneers compared to those bonded onto intact teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is an evaluative prospective study where over 450 laminate veneers were made in 110 patients. All patients will be asked to enrol in the study. Probably 90% will come to an evaluation appointment when asked to enrol. 90% seems very high but all patients were formerly patients when dr. Gresnigt was still working in a private general dentistry office. So reasonably 400 laminate veneers with 100 patients will be expected to be evaluated.
Key inclusion criteria (4 listed)
- All patients treated with laminate veneers by dr. Gresnigt
- at least 18 years old
- able to read and sign the informed consent document
- physically and psychologically able come for an evaluation as outlined by the investigators.
Key exclusion criteria (2 listed)
- People not able to return or not willing to come for an evaluation
- People died
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 |
|---|---|---|
| checkup, no testIn this study we would like to examine if existing restorations already applied in teeth which we treated with laminate veneers had an effect. We will evaluate the laminate veneers by sight and take pictures and use a questionnaire | Diagnostic test | – |
Primary outcome
Restorations which survived when applied on the tooth till the last follow up. (survival)
Time frame: june 2007- september 2018
Caries, debonding, chipping, and fracture are considered as absolute failures. Due to these factors the restorations will be lost and a new one has to be made, that is why these scores are survival and main endpoints.
1 secondary outcome
Succes
Time frame: june 2007 - september 2018
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.
- Background: PubMed 15119590Peumans M, De Munck J, Fieuws S, Lambrechts P, Vanherle G, Van Meerbeek B. A prospective ten-year clinical trial of porcelain veneers. J Adhes Dent. 2004 Spring;6(1):65-76.
- Background: PubMed 29079354Gresnigt MMM, Ozcan M, Carvalho M, Lazari P, Cune MS, Razavi P, Magne P. Effect of luting agent on the load to failure and accelerated-fatigue resistance of lithium disilicate laminate veneers. Dent Mater. 2017 Dec;33(12):1392-1401. doi: 10.1016/j.dental.2017.09.010. Epub 2017 Nov 1.
- Background: PubMed 26856454Gresnigt MM, Cune MS, de Roos JG, Ozcan M. Effect of immediate and delayed dentin sealing on the fracture strength, failure type and Weilbull characteristics of lithiumdisilicate laminate veneers. Dent Mater. 2016 Apr;32(4):e73-81. doi: 10.1016/j.dental.2016.01.001. Epub 2016 Feb 5.
- Background: PubMed 23534025Gresnigt MM, Kalk W, Ozcan M. Randomized clinical trial of indirect resin composite and ceramic veneers: up to 3-year follow-up. J Adhes Dent. 2013 Apr;15(2):181-90. doi: 10.3290/j.jad.a28883.
- Background: PubMed 22821429Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
- Background: PubMed 21876866Gresnigt M, Ozcan M, Kalk W. Esthetic rehabilitation of worn anterior teeth with thin porcelain laminate veneers. Eur J Esthet Dent. 2011 Autumn;6(3):298-313.
- Background: PubMed 21734979Gresnigt MM, Ozcan M, Kalk W, Galhano G. Effect of static and cyclic loading on ceramic laminate veneers adhered to teeth with and without aged composite restorations. J Adhes Dent. 2011 Dec;13(6):569-77. doi: 10.3290/j.jad.a21742.
- Derived from this study: PubMed 31084936Gresnigt MMM, Cune MS, Schuitemaker J, van der Made SAM, Meisberger EW, Magne P, Ozcan M. Performance of ceramic laminate veneers with immediate dentine sealing: An 11 year prospective clinical trial. Dent Mater. 2019 Jul;35(7):1042-1052. doi: 10.1016/j.dental.2019.04.008. Epub 2019 May 10.
- Individual participant dataSharing planned: No. This study will focus on laminate veneers bonded to teeth with and without composite restorations. And also will be looked at preparations were more than 50% of dentin was exposed if an immediate dentin sealing would have an benefit.
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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.
Marco Cune, Prof principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Restoration Failure of Marginal Integrity, run by University Medical Center Groningen.
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 2 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.
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 Marco Gresnigt, Dr (0031647494611, marcogresnigt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restorations which survived when applied on the tooth till the last follow up. (survival) (time frame: june 2007- september 2018). 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 NCT03645551, which also lists 8 linked publications.
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.