Tooth FracturefacingsNCT03145597
Survival Rate of Adhesively Luted Veneers
A study testing Laminate veneer of composite and Laminate veneer of ceramic in people with Tooth Fracture, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Fracture
- What is being tested?
- Laminate veneer of composite and Laminate veneer of ceramic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mutlu Ozcan, Prof contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713AV
marco gresnigt, doctor, 0031647494611, marcogresnigt@yahoo.com
marco gresnigt, doctor
About this study
Official title: Survival Rate of Adhesively Luted Veneers, an In-vivo Study
The aims of this clinical study are:
To evaluate the clinical performance between indirect composite and ceramic laminate veneers:
Read more
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.
Read the 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".
- Conditions
- Tooth Fracture
- Being tested
- Laminate veneer of composite, Laminate veneer of ceramic
- Keywords
- facings, veneers, laminates, existing, restorations, esthetics, dental
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminate veneer of compositeDevice
Composite laminate veneers, 2-4-6 veneers per patient
Laminate veneer of ceramicDevice
laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
| Study group | Role | What they receive |
|---|---|---|
| Laminate veneer of composite | Experimental | Laminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made. Receives: Device: Laminate veneer of composite |
| Laminate veneer of ceramic | Experimental | laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made. Receives: Device: Laminate veneer of ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of laminate veneers
fracture of teeth
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jun 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Tooth FractureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gresnigt, University Medical Center Groningen
- Investigators
- Marco Gresnigt, Phd, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145597
- Sponsor's protocol ID
- Laminate veneers
- Acronym
- facings
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2012
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12644802Blatz 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.
PubMed 15301212Brendeke J, Ozcan M. Effect of physicochemical aging conditions on the composite-composite repair bond strength. J Adhes Dent. 2007 Aug;9(4):399-406.
PubMed 17847643Brentel 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.
PubMed 17188745Busscher 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.
PubMed 20448246Ccahuana 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.
PubMed 20485927Carlen 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.
PubMed 11214759Drummond JL. Degradation, fatigue, and failure of resin dental composite materials. J Dent Res. 2008 Aug;87(8):710-9. doi: 10.1177/154405910808700802.
PubMed 18650540Dumfahrt 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.
PubMed 11203615Dunne 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.
PubMed 8251248Ernest 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.
PubMed 15779314Ferracane 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.
PubMed 9788511Ferracane 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.
PubMed 8595835Fradeani M. Six-year follow-up with Empress veneers. Int J Periodontics Restorative Dent. 1998 Jun;18(3):216-25.
PubMed 9728104Fradeani 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.
PubMed 15736774
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Rate of Adhesively Luted Veneers, an In-vivo Study
- ClinicalTrials.gov ID
- NCT03145597
- Acronym / sponsor ID
- facings / Laminate veneers
- Conditions
- Tooth Fracture
- Keywords
- facings, veneers, laminates, existing, restorations, esthetics, dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split mouth comparison
| Arm | Type | Receives |
|---|---|---|
| Laminate veneer of composite | Experimental | Device: Laminate veneer of compositeLaminate veneer of composite (Estenia, Kuraray Dental), composite laminate veneer, 2-4-6 veneers per patient will be made. |
| Laminate veneer of ceramic | Experimental | Device: Laminate veneer of ceramiclaminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laminate veneer of compositeComposite laminate veneers, 2-4-6 veneers per patient | Device | Laminate veneer of composite |
| Laminate veneer of ceramiclaminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made. | Device | Laminate veneer of ceramic |
Primary outcome
survival rate of laminate veneers
Time frame: up to 24 months
fracture of teeth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Background: PubMed 12644802Blatz 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.
- Background: PubMed 15301212Blatz 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.
- Background: PubMed 17847643Brendeke J, Ozcan M. Effect of physicochemical aging conditions on the composite-composite repair bond strength. J Adhes Dent. 2007 Aug;9(4):399-406.
- Background: PubMed 17188745Brentel 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.
- Background: PubMed 20448246Busscher 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.
- Background: PubMed 20485927Ccahuana 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.
- Background: PubMed 11214759Carlen 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.
- Background: PubMed 18650540Drummond JL. Degradation, fatigue, and failure of resin dental composite materials. J Dent Res. 2008 Aug;87(8):710-9. doi: 10.1177/154405910808700802.
- Background: PubMed 11203615Dumfahrt 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.
- Background: PubMed 8251248Dunne 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.
- Background: PubMed 15779314Ernest 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.
- Background: PubMed 9788511Ferracane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mutlu Ozcan, Prof contact
Marco Gresnigt, Phd principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminate veneer of composite and Laminate veneer of ceramic in people with Tooth Fracture, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marco Gresnigt, Phd (0031-50-3632608, marcogresnigt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate of laminate veneers (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145597, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.