Survival Rate of Adhesively Luted Veneers (facings)
Primary Purpose
Tooth Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Laminate veneer of composite
Laminate veneer of ceramic
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Fracture focused on measuring facings, veneers, laminates, existing, restorations, esthetics, dental
Eligibility Criteria
Inclusion Criteria:
- The veneers will be placed on central incisors, lateral incisors, canines in the maxilla. Indications will involve replacing worn, discoloured composite restorations and existing veneers, or correcting discoloured, malformed and/or misaligned teeth.
- An indication for closure of the open space (diastema)
- No obvious untreated caries, dental health problems (regularly checked by a dentist).
- No untreated periodontal disease (allowed are DPSI 1, 2, 3-)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment).
- Endodontic treatment with good outcome (root canal densely filled with gutta-percha 0.5-1.5 mm from apex) with only a restoration on palatinal side.
- The patient agrees with the research protocol (signing of an agreement form, appendix 4)
- 18 Year and older.
Exclusion Criteria:
- Patients with only one tooth to restore, or two central incisors.
- Considerable horizontal and/or vertical mobility of abutment teeth: tooth mobility index score 2 or 3.
- Considerable periodontal disease without treatment (DPSI 3+ and 4)
- Endodontic treatment with extensive loss of tooth tissue (more than 2/3 of crown is restored with restoration material).
- Restoration of whole crown, more than 2/3 of coronal part of the teeth is restored.
- Patients that still want to bleach their teeth or bleached teeth less than 3 weeks before the treatment.
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laminate veneer of composite
Laminate veneer of ceramic
Arm Description
Laminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made.
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
Outcomes
Primary Outcome Measures
survival rate of laminate veneers
fracture of teeth
Secondary Outcome Measures
Full Information
NCT ID
NCT03145597
First Posted
June 12, 2012
Last Updated
August 21, 2018
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03145597
Brief Title
Survival Rate of Adhesively Luted Veneers
Acronym
facings
Official Title
Survival Rate of Adhesively Luted Veneers, an In-vivo Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aims of this clinical study are:
To evaluate the clinical performance between indirect composite and ceramic laminate veneers:
Main interests are:
colour stability of the restoration (digital measurement in follow up)
failure mode of the restoration
wear of the restoration and antagonist
Hypothesis:
The colour stability of indirect composite restorations will not be different from the ceramic restorations.
The indirect composite restorations will not be more prone to failure than the ceramic restorations.
Antagonist wear and restorative material wear will be similar for both ceramic and composite.
Material and Methods The laminates will be fabricated according to a specified protocol. In order to avoid possible noticeable differences in case of distinct levels of possible discoloration, a modified split mouth design is employed where the central incisors and the symmetric other teeth receive the same type of restoration. Randomization is based on the paired teeth and it is performed using the flip of a coin for the choice of material. Evaluation will be performed at baseline and at follow-up visits annually up to 2 years.
Detailed Description
Patient recruitment: Patients will be recruited from the university clinic.
Intake: If the patient is included in the study following the inclusion and exclusion criteria, the patient will be evaluated using the evaluation form. All the data will be collected and impressions will be made. Using the impressions, a wax up will be made on stone models indicating the restorations to be fabricated. With a transparent mould, the situation will be duplicated in the mouth with spot etching and composite. By using this protocol minimal loss of tooth material is guaranteed.
Tooth Preparation: After prophylaxis, the teeth will be prepared in a controlled manner using special depth cutting laminate preparation burs (Intensive, Switzerland). The margins will extend to half the way to the inter-proximal contact area. The shape of the cervical margins will be maintained in chamfer form. The incisal edge will be prepared 1.5 mm to create an overlap to the palatinal region for the translucency area in the laminate veneers.
Conditioning the tooth surface: Rubberdam will be placed. The preparation surfaces will be etched with 35% phosphoric acid, rinsed thoroughly and dried followed by the application of primer and the bonding agent.
Conditioning the existing restorations: The existing composite restaurations will be conditioned using tribochemical silicacoating (CoJet, 30µm SiOx, 3M ESPE) in a Dentoprep (Ronvig, Denmark) intraoral sandblaster. Following this the restauration will be conditioned by silanisation.
Conditioning the composite veneers: The inner surfaces of the indirect composite laminates will rinsed with alcohol and thereafter conditioned using tribochemical silicacoating (CoJet, 30µm SiOx, 3M ESPE) using an (Ronvig, Denmark) intra-oral sandblaster. The sandblasting will be approx 13 sec until the inner surface of the restoration change colour visually. Following this the inner surface will be conditioned by silanisation.
Conditioning the ceramic veneers: The inner surfaces of the ceramic laminates will be conditioned with hydrofluoric acid 5% and rinsed in neutralizing agent, ultrasonically cleaned and then silanized.
After insertion, the excess composite will be removed using handinstruments and finishing burs under continuous water-cooling. Finally the margins will be polished using diamond polishing-paste with a rotating rubber cup. The interproximal surfaces will be finished with Sof-Lex polishing disks and strips.
Cementing the restorations: The cementation medium will be a dual-cure aesthetic adhesive cement Variolink veneer. All adhesive restorations will be cemented using ultrasonic insertion techniques. Cementation of the indirect restorations will be performed according to a protocol presented in appendix 2: "Clinical procedures".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fracture
Keywords
facings, veneers, laminates, existing, restorations, esthetics, dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth comparison
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laminate veneer of composite
Arm Type
Experimental
Arm Description
Laminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made.
Arm Title
Laminate veneer of ceramic
Arm Type
Experimental
Arm Description
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
Intervention Type
Device
Intervention Name(s)
Laminate veneer of composite
Intervention Description
Composite laminate veneers, 2-4-6 veneers per patient
Intervention Type
Device
Intervention Name(s)
Laminate veneer of ceramic
Intervention Description
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
Primary Outcome Measure Information:
Title
survival rate of laminate veneers
Description
fracture of teeth
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The veneers will be placed on central incisors, lateral incisors, canines in the maxilla. Indications will involve replacing worn, discoloured composite restorations and existing veneers, or correcting discoloured, malformed and/or misaligned teeth.
An indication for closure of the open space (diastema)
No obvious untreated caries, dental health problems (regularly checked by a dentist).
No untreated periodontal disease (allowed are DPSI 1, 2, 3-)
Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment).
Endodontic treatment with good outcome (root canal densely filled with gutta-percha 0.5-1.5 mm from apex) with only a restoration on palatinal side.
The patient agrees with the research protocol (signing of an agreement form, appendix 4)
18 Year and older.
Exclusion Criteria:
Patients with only one tooth to restore, or two central incisors.
Considerable horizontal and/or vertical mobility of abutment teeth: tooth mobility index score 2 or 3.
Considerable periodontal disease without treatment (DPSI 3+ and 4)
Endodontic treatment with extensive loss of tooth tissue (more than 2/3 of crown is restored with restoration material).
Restoration of whole crown, more than 2/3 of coronal part of the teeth is restored.
Patients that still want to bleach their teeth or bleached teeth less than 3 weeks before the treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marco Gresnigt, Phd
Phone
0031-50-3632608
Email
marcogresnigt@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mutlu Ozcan, Prof
Email
mutluozcan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Gresnigt, Phd
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713AV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marco gresnigt, doctor
Phone
0031647494611
Email
marcogresnigt@yahoo.com
First Name & Middle Initial & Last Name & Degree
marco gresnigt, doctor
First Name & Middle Initial & Last Name & Degree
Marco Cune, professor
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12644802
Citation
Blatz MB, Sadan A, Kern M. Resin-ceramic bonding: a review of the literature. J Prosthet Dent. 2003 Mar;89(3):268-74. doi: 10.1067/mpr.2003.50.
Results Reference
background
PubMed Identifier
15301212
Citation
Blatz MB, Sadan A, Maltezos C, Blatz U, Mercante D, Burgess JO. In vitro durability of the resin bond to feldspathic ceramics. Am J Dent. 2004 Jun;17(3):169-72.
Results Reference
background
PubMed Identifier
17847643
Citation
Brendeke J, Ozcan M. Effect of physicochemical aging conditions on the composite-composite repair bond strength. J Adhes Dent. 2007 Aug;9(4):399-406.
Results Reference
background
PubMed Identifier
17188745
Citation
Brentel AS, Ozcan M, Valandro LF, Alarca LG, Amaral R, Bottino MA. Microtensile bond strength of a resin cement to feldpathic ceramic after different etching and silanization regimens in dry and aged conditions. Dent Mater. 2007 Nov;23(11):1323-31. doi: 10.1016/j.dental.2006.11.011. Epub 2006 Dec 26.
Results Reference
background
PubMed Identifier
20448246
Citation
Busscher HJ, Rinastiti M, Siswomihardjo W, van der Mei HC. Biofilm formation on dental restorative and implant materials. J Dent Res. 2010 Jul;89(7):657-65. doi: 10.1177/0022034510368644. Epub 2010 May 6.
Results Reference
background
PubMed Identifier
20485927
Citation
Ccahuana VZ, Ozcan M, Mesquita AM, Nishioka RS, Kimpara ET, Bottino MA. Surface degradation of glass ceramics after exposure to acidulated phosphate fluoride. J Appl Oral Sci. 2010 Mar-Apr;18(2):155-65. doi: 10.1590/s1678-77572010000200010.
Results Reference
background
PubMed Identifier
11214759
Citation
Carlen A, Nikdel K, Wennerberg A, Holmberg K, Olsson J. Surface characteristics and in vitro biofilm formation on glass ionomer and composite resin. Biomaterials. 2001 Mar;22(5):481-7. doi: 10.1016/s0142-9612(00)00204-0.
Results Reference
background
PubMed Identifier
18650540
Citation
Drummond JL. Degradation, fatigue, and failure of resin dental composite materials. J Dent Res. 2008 Aug;87(8):710-9. doi: 10.1177/154405910808700802.
Results Reference
background
PubMed Identifier
11203615
Citation
Dumfahrt H, Schaffer H. Porcelain laminate veneers. A retrospective evaluation after 1 to 10 years of service: Part II--Clinical results. Int J Prosthodont. 2000 Jan-Feb;13(1):9-18.
Results Reference
background
PubMed Identifier
8251248
Citation
Dunne SM, Millar BJ. A longitudinal study of the clinical performance of porcelain veneers. Br Dent J. 1993 Nov 6;175(9):317-21. doi: 10.1038/sj.bdj.4808314.
Results Reference
background
PubMed Identifier
15779314
Citation
Ernest CP, Holzmeier M, Willershausen B. In vitro shear bond strength of self-etching adhesives in comparison to 4th and 5th generation adhesives. J Adhes Dent. 2004 Winter;6(4):293-9.
Results Reference
background
PubMed Identifier
9788511
Citation
Ferracane JL, Berge HX, Condon JR. In vitro aging of dental composites in water--effect of degree of conversion, filler volume, and filler/matrix coupling. J Biomed Mater Res. 1998 Dec 5;42(3):465-72. doi: 10.1002/(sici)1097-4636(19981205)42:33.0.co;2-f.
Results Reference
background
PubMed Identifier
8595835
Citation
Ferracane JL, Hopkin JK, Condon JR. Properties of heat-treated composites after aging in water. Dent Mater. 1995 Nov;11(6):354-8. doi: 10.1016/0109-5641(95)80034-4.
Results Reference
background
PubMed Identifier
9728104
Citation
Fradeani M. Six-year follow-up with Empress veneers. Int J Periodontics Restorative Dent. 1998 Jun;18(3):216-25.
Results Reference
background
PubMed Identifier
15736774
Citation
Fradeani M, Redemagni M, Corrado M. Porcelain laminate veneers: 6- to 12-year clinical evaluation--a retrospective study. Int J Periodontics Restorative Dent. 2005 Feb;25(1):9-17.
Results Reference
background
PubMed Identifier
9693518
Citation
Friedman MJ. A 15-year review of porcelain veneer failure--a clinician's observations. Compend Contin Educ Dent. 1998 Jun;19(6):625-8, 630, 632 passim; quiz 638.
Results Reference
background
PubMed Identifier
18621456
Citation
Fucio SB, Carvalho FG, Sobrinho LC, Sinhoreti MA, Puppin-Rontani RM. The influence of 30-day-old Streptococcus mutans biofilm on the surface of esthetic restorative materials--an in vitro study. J Dent. 2008 Oct;36(10):833-9. doi: 10.1016/j.jdent.2008.06.002. Epub 2008 Jul 14.
Results Reference
background
PubMed Identifier
9108746
Citation
Fuzzi M, Zaccheroni Z, Vallania G. Scanning electron microscopy and profilometer evaluation of glazed and polished dental porcelain. Int J Prosthodont. 1996 Sep-Oct;9(5):452-8.
Results Reference
background
PubMed Identifier
8624387
Citation
Gopferich A. Mechanisms of polymer degradation and erosion. Biomaterials. 1996 Jan;17(2):103-14. doi: 10.1016/0142-9612(96)85755-3.
Results Reference
background
PubMed Identifier
15779317
Citation
Goracci C, Sadek FT, Monticelli F, Cardoso PE, Ferrari M. Microtensile bond strength of self-etching adhesives to enamel and dentin. J Adhes Dent. 2004 Winter;6(4):313-8.
Results Reference
background
PubMed Identifier
21594236
Citation
Gresnigt M, Ozcan M, Muis M, Kalk W. Bonding of glass ceramic and indirect composite to non-aged and aged resin composite. J Adhes Dent. 2012 Feb;14(1):59-68. doi: 10.3290/j.jad.a21418.
Results Reference
background
PubMed Identifier
18006051
Citation
Guess PC, Stappert CF. Midterm results of a 5-year prospective clinical investigation of extended ceramic veneers. Dent Mater. 2008 Jun;24(6):804-13. doi: 10.1016/j.dental.2007.09.009. Epub 2007 Nov 19.
Results Reference
background
PubMed Identifier
12680057
Citation
Gurel G. Predictable, precise, and repeatable tooth preparation for porcelain laminate veneers. Pract Proced Aesthet Dent. 2003 Jan-Feb;15(1):17-24; quiz 26.
Results Reference
background
PubMed Identifier
1290574
Citation
Karlsson S, Landahl I, Stegersjo G, Milleding P. A clinical evaluation of ceramic laminate veneers. Int J Prosthodont. 1992 Sep-Oct;5(5):447-51.
Results Reference
background
PubMed Identifier
11504440
Citation
Kawai K, Urano M. Adherence of plaque components to different restorative materials. Oper Dent. 2001 Jul-Aug;26(4):396-400.
Results Reference
background
PubMed Identifier
17122161
Citation
Kramer N, Kunzelmann KH, Taschner M, Mehl A, Garcia-Godoy F, Frankenberger R. Antagonist enamel wears more than ceramic inlays. J Dent Res. 2006 Dec;85(12):1097-100. doi: 10.1177/154405910608501206.
Results Reference
background
PubMed Identifier
12102187
Citation
Lateef SS, Boateng S, Hartman TJ, Crot CA, Russell B, Hanley L. GRGDSP peptide-bound silicone membranes withstand mechanical flexing in vitro and display enhanced fibroblast adhesion. Biomaterials. 2002 Aug;23(15):3159-68. doi: 10.1016/s0142-9612(02)00062-5.
Results Reference
background
PubMed Identifier
12071917
Citation
Leloup G, Holvoet PE, Bebelman S, Devaux J. Raman scattering determination of the depth of cure of light-activated composites: influence of different clinically relevant parameters. J Oral Rehabil. 2002 Jun;29(6):510-5. doi: 10.1046/j.1365-2842.2002.00889.x.
Results Reference
background
PubMed Identifier
15259539
Citation
Magne P, Belser UC. Novel porcelain laminate preparation approach driven by a diagnostic mock-up. J Esthet Restor Dent. 2004;16(1):7-16; discussion 17-8. doi: 10.1111/j.1708-8240.2004.tb00444.x.
Results Reference
background
PubMed Identifier
9754744
Citation
Meijering AC, Creugers NH, Roeters FJ, Mulder J. Survival of three types of veneer restorations in a clinical trial: a 2.5-year interim evaluation. J Dent. 1998 Sep;26(7):563-8. doi: 10.1016/s0300-5712(97)00032-8.
Results Reference
background
PubMed Identifier
12011863
Citation
Oh WS, Delong R, Anusavice KJ. Factors affecting enamel and ceramic wear: a literature review. J Prosthet Dent. 2002 Apr;87(4):451-9. doi: 10.1067/mpr.2002.123851.
Results Reference
background
PubMed Identifier
1292463
Citation
Oilo G. Biodegradation of dental composites/glass-ionomer cements. Adv Dent Res. 1992 Sep;6:50-4. doi: 10.1177/08959374920060011701.
Results Reference
background
PubMed Identifier
17655069
Citation
Onisor I, Bouillaguet S, Krejci I. Influence of different surface treatments on marginal adaptation in enamel and dentin. J Adhes Dent. 2007 Jun;9(3):297-303.
Results Reference
background
PubMed Identifier
15754140
Citation
Ozcan M, Alander P, Vallittu PK, Huysmans MC, Kalk W. Effect of three surface conditioning methods to improve bond strength of particulate filler resin composites. J Mater Sci Mater Med. 2005 Jan;16(1):21-7. doi: 10.1007/s10856-005-6442-4.
Results Reference
background
PubMed Identifier
17174388
Citation
Ozcan M, Barbosa SH, Melo RM, Galhano GA, Bottino MA. Effect of surface conditioning methods on the microtensile bond strength of resin composite to composite after aging conditions. Dent Mater. 2007 Oct;23(10):1276-82. doi: 10.1016/j.dental.2006.11.007. Epub 2006 Dec 15.
Results Reference
background
PubMed Identifier
19189676
Citation
Passos SP, Valandro LF, Amaral R, Ozcan M, Bottino MA, Kimpara ET. Does adhesive resin application contribute to resin bond durability on etched and silanized feldspathic ceramic? J Adhes Dent. 2008 Dec;10(6):455-60.
Results Reference
background
PubMed Identifier
15119590
Citation
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.
Results Reference
background
PubMed Identifier
19735692
Citation
Rinastiti M, Ozcan M, Siswomihardjo W, Busscher HJ. Immediate repair bond strengths of microhybrid, nanohybrid and nanofilled composites after different surface treatments. J Dent. 2010 Jan;38(1):29-38. doi: 10.1016/j.jdent.2009.08.009.
Results Reference
background
PubMed Identifier
20940354
Citation
Rinastiti M, Ozcan M, Siswomihardjo W, Busscher HJ, van der Mei HC. Effect of biofilm on the repair bond strengths of composites. J Dent Res. 2010 Dec;89(12):1476-81. doi: 10.1177/0022034510381395. Epub 2010 Oct 12.
Results Reference
background
PubMed Identifier
20040031
Citation
Souza RO, Ozcan M, Michida SM, de Melo RM, Pavanelli CA, Bottino MA, Soares LE, Martin AA. Conversion degree of indirect resin composites and effect of thermocycling on their physical properties. J Prosthodont. 2010 Apr;19(3):218-25. doi: 10.1111/j.1532-849X.2009.00551.x. Epub 2009 Dec 21.
Results Reference
background
PubMed Identifier
17007919
Citation
Takeshige F, Kawakami Y, Hayashi M, Ebisu S. Fatigue behavior of resin composites in aqueous environments. Dent Mater. 2007 Jul;23(7):893-9. doi: 10.1016/j.dental.2006.06.031. Epub 2006 Sep 27.
Results Reference
background
PubMed Identifier
14974066
Citation
Wakiaga J, Brunton P, Silikas N, Glenny AM. Direct versus indirect veneer restorations for intrinsic dental stains. Cochrane Database Syst Rev. 2004;(1):CD004347. doi: 10.1002/14651858.CD004347.pub2.
Results Reference
background
PubMed Identifier
3244054
Citation
Walls AW, Murray JJ, McCabe JF. Composite laminate veneers: a clinical study. J Oral Rehabil. 1988 Sep;15(5):439-54. doi: 10.1111/j.1365-2842.1988.tb00180.x.
Results Reference
background
Learn more about this trial
Survival Rate of Adhesively Luted Veneers
We'll reach out to this number within 24 hrs