Clinical trial NCT03145597: Survival Rate of Adhesively Luted Veneers
Official title: Survival Rate of Adhesively Luted Veneers, an In-vivo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Fracture
Keywords: facings
veneers
laminates
existing
restorations
esthetics
dental
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth comparison
Primary purpose: TREATMENT

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".

Eligibility criteria: Inclusion Criteria:

1. 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.
2. An indication for closure of the open space (diastema)
3. No obvious untreated caries, dental health problems (regularly checked by a dentist).
4. No untreated periodontal disease (allowed are DPSI 1, 2, 3-)
5. Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment).
6. 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.
7. The patient agrees with the research protocol (signing of an agreement form, appendix 4)
8. 18 Year and older.

Exclusion Criteria:

1. Patients with only one tooth to restore, or two central incisors.
2. Considerable horizontal and/or vertical mobility of abutment teeth: tooth mobility index score 2 or 3.
3. Considerable periodontal disease without treatment (DPSI 3+ and 4)
4. Endodontic treatment with extensive loss of tooth tissue (more than 2/3 of crown is restored with restoration material).
5. Restoration of whole crown, more than 2/3 of coronal part of the teeth is restored.
6. Patients that still want to bleach their teeth or bleached teeth less than 3 weeks before the treatment.

Primary outcomes:
measure: survival rate of laminate veneers
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Marco Gresnigt, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Fradeani M. Six-year follow-up with Empress veneers. Int J Periodontics Restorative Dent. 1998 Jun;18(3):216-25.
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.
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.
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.
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.
citation: Gopferich A. Mechanisms of polymer degradation and erosion. Biomaterials. 1996 Jan;17(2):103-14. doi: 10.1016/0142-9612(96)85755-3.
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.
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.
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.
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.
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.
citation: Kawai K, Urano M. Adherence of plaque components to different restorative materials. Oper Dent. 2001 Jul-Aug;26(4):396-400.
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.
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.
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.
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.
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.
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.
citation: Oilo G. Biodegradation of dental composites/glass-ionomer cements. Adv Dent Res. 1992 Sep;6:50-4. doi: 10.1177/08959374920060011701.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.