The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Longevity of Ceramic Laminate Veneers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Marco Gresnigt, University Medical Center Groningen

Tracking Information
First Submitted Date August 21, 2018
First Posted Date August 24, 2018
Last Update Posted Date April 16, 2019
Estimated Study Start Date May 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 22, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Longevity of Ceramic Laminate Veneers
Official Title Clinical Longevity of Ceramic Laminate Veneers Bonded to Teeth With and Without Existing Composite Restorations up to 10 Years
Brief 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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition Dental Restoration Failure of Marginal Integrity
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 22, 2018)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03645551
Other Study ID Numbers Gresnigt
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Current Responsible Party Marco Gresnigt, University Medical Center Groningen
Original Responsible Party Same as current
Current Study Sponsor University Medical Center Groningen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Marco Cune, Prof University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date April 2019