- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645551
Clinical Longevity of Ceramic Laminate Veneers
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.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marco Gresnigt, Dr
- Phone Number: 0031647494611
- Email: marcogresnigt@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- People not able to return or not willing to come for an evaluation
- People died
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
june 2007- september 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Succes
Time Frame: june 2007 - september 2018
|
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.
|
june 2007 - september 2018
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marco Cune, Prof, University Medical Center Groningen
Publications and helpful links
General 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.
- Gresnigt 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.
- Gresnigt 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.
- Gresnigt 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.
- Gresnigt 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.
- Gresnigt 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.
- Gresnigt 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.
- Gresnigt 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Gresnigt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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