Clinical Longevity of Ceramic Laminate Veneers
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|ClinicalTrials.gov Identifier: NCT03645551|
Recruitment Status : Unknown
Verified April 2019 by Marco Gresnigt, University Medical Center Groningen.
Recruitment status was: Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : April 16, 2019
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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.
|Condition or disease||Intervention/treatment|
|Dental Restoration Failure of Marginal Integrity||Diagnostic Test: checkup, no test|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Clinical Longevity of Ceramic Laminate Veneers Bonded to Teeth With and Without Existing Composite Restorations up to 10 Years|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2020|
- Diagnostic Test: checkup, no 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
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- 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.
- People not able to return or not willing to come for an evaluation
- People died
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645551
|Contact: Marco Gresnigt, Drfirstname.lastname@example.org|
|Principal Investigator:||Marco Cune, Prof||University Medical Center Groningen|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Marco Gresnigt, independent investigator, University Medical Center Groningen|
|Other Study ID Numbers:||
|First Posted:||August 24, 2018 Key Record Dates|
|Last Update Posted:||April 16, 2019|
|Last Verified:||April 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|