NCT03112278

Brief Summary

Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of patients affected by moderate and severe dental erosion.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

April 4, 2017

Last Update Submit

October 24, 2017

Conditions

Keywords

tooth erosionComputer-Aided Designocclusal veneersdental veneers

Outcome Measures

Primary Outcomes (1)

  • Survival of ultrathin occlusal veneers (ceramic and composite resin) for the restorative treatment of severe dental erosion.

    1Year

Study Arms (2)

Ceramic restorations

ACTIVE COMPARATOR

Ceramic ultrathin occlusal veneers

Procedure: Ceramic ultrathin occlusal veneers

Composite resin restorations

ACTIVE COMPARATOR

Composite resin ultrathin occlusal veneers

Procedure: Composite resin ultrathin occlusal veneers

Interventions

Severely eroded teeth will be restored with ultrathin occlusal veneers made of ceramic (e.max CAD/Ivoclar Vivadent) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).

Ceramic restorations

Severely eroded teeth will be restored ultrathin occlusal veneers made of composite resin (Lava Ultimate/3M Espe) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).

Composite resin restorations

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting advanced erosive lesions ( cumulative score in all sextants greater than or equal 14, according to classification of BARLETT; GANSS; LUSSI, 2008).
  • Absence of pain from the tooth to be restored (excluding expected sensitivity due to dentin exposure due to severe erosion).
  • Application of rubber dam possible
  • High level of oral hygiene.
  • Absence of any active periodontal and pulpal disease.
  • Willingness to wear a nightguard to protect the restorations in case of associated bruxism.

You may not qualify if:

  • patients with low level of oral hygiene after all the attempts to improve it failed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Bindl A, Mormann WH. Survival rate of mono-ceramic and ceramic-core CAD/CAM-generated anterior crowns over 2-5 years. Eur J Oral Sci. 2004 Apr;112(2):197-204. doi: 10.1111/j.1600-0722.2004.00119.x.

    PMID: 15056119BACKGROUND
  • Burke FJ. Maximising the fracture resistance of dentine-bonded all-ceramic crowns. J Dent. 1999 Mar;27(3):169-73. doi: 10.1016/s0300-5712(98)00050-5.

    PMID: 10079622BACKGROUND
  • Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for posterior teeth. Int J Periodontics Restorative Dent. 2002 Jun;22(3):241-9.

    PMID: 12186346BACKGROUND
  • Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for anterior teeth. J Prosthet Dent. 2002 May;87(5):503-9. doi: 10.1067/mpr.2002.124094.

    PMID: 12070513BACKGROUND
  • Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH. Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont. 2004 May-Jun;17(3):313-7.

    PMID: 15237878BACKGROUND
  • Jaeggi T, Lussi A. Prevalence, incidence and distribution of erosion. Monogr Oral Sci. 2006;20:44-65. doi: 10.1159/000093350.

    PMID: 16687884BACKGROUND
  • Kunzelmann KH, Jelen B, Mehl A, Hickel R. Wear evaluation of MZ100 compared to ceramic CAD/CAM materials. Int J Comput Dent. 2001 Jul;4(3):171-84. English, German.

    PMID: 11862884BACKGROUND
  • Leinfelder KF. Ask the expert. Will ceramic restorations be challenged in the future? J Am Dent Assoc. 2001 Jan;132(1):46-7. doi: 10.14219/jada.archive.2001.0024. No abstract available.

    PMID: 11194398BACKGROUND
  • Lussi A, Hellwig E, Ganss C, Jaeggi T. Buonocore Memorial Lecture. Dental erosion. Oper Dent. 2009 May-Jun;34(3):251-62. doi: 10.2341/09-BL.

    PMID: 19544813BACKGROUND
  • Magne P. Composite resins and bonded porcelain: the postamalgam era? J Calif Dent Assoc. 2006 Feb;34(2):135-47.

    PMID: 16724469BACKGROUND
  • Magne P, Schlichting LH, Maia HP, Baratieri LN. In vitro fatigue resistance of CAD/CAM composite resin and ceramic posterior occlusal veneers. J Prosthet Dent. 2010 Sep;104(3):149-57. doi: 10.1016/S0022-3913(10)60111-4.

    PMID: 20813228BACKGROUND
  • Manhart J, Chen H, Hamm G, Hickel R. Buonocore Memorial Lecture. Review of the clinical survival of direct and indirect restorations in posterior teeth of the permanent dentition. Oper Dent. 2004 Sep-Oct;29(5):481-508.

    PMID: 15470871BACKGROUND
  • Magne P, Stanley K, Schlichting LH. Modeling of ultrathin occlusal veneers. Dent Mater. 2012 Jul;28(7):777-82. doi: 10.1016/j.dental.2012.04.002. Epub 2012 May 9.

    PMID: 22575740BACKGROUND
  • Schlichting LH, Maia HP, Baratieri LN, Magne P. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion. J Prosthet Dent. 2011 Apr;105(4):217-26. doi: 10.1016/S0022-3913(11)60035-8.

    PMID: 21458646BACKGROUND
  • Tsitrou EA, van Noort R. Minimal preparation designs for single posterior indirect prostheses with the use of the Cerec system. Int J Comput Dent. 2008;11(3-4):227-40. English, German.

    PMID: 19216314BACKGROUND
  • Vailati F, Belser UC. Full-mouth adhesive rehabilitation of a severely eroded dentition: the three-step technique. Part 1. Eur J Esthet Dent. 2008 Spring;3(1):30-44.

    PMID: 19655557BACKGROUND
  • Schlichting LH, Resende TH, Reis KR, Magne P. Simplified treatment of severe dental erosion with ultrathin CAD-CAM composite occlusal veneers and anterior bilaminar veneers. J Prosthet Dent. 2016 Oct;116(4):474-482. doi: 10.1016/j.prosdent.2016.02.013. Epub 2016 Apr 29.

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth Wear

Study Officials

  • Luis H Schlichting, PhD

    Federal University of Rio de Janeiro and East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Both patient and the evaluators that will asses the performance of the restorations are unaware about the type of material used to fabricate the occlusal veneers
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

November 1, 2015

Primary Completion

April 14, 2017

Study Completion

April 2, 2021

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share