NCT02861729

Brief Summary

The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

August 4, 2016

Last Update Submit

February 4, 2019

Conditions

Partial Coverage Restoration

Keywords

Partial coverage restorationCrownPosterior teethAll ceramicZirconia reinforced lithium silicateLithium disilicateCAD/CAM

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Absolute failure is defined by clinical unacceptable fracture and crack development which required a replacement of the entire restoration, and/or secondary caries as well as endodontic complications

    12 month

Secondary Outcomes (5)

  • Restorations with Marginal gap as assessed visually by US public health service criteria

    12 month

  • Restorations with Marginal discoloration as assessed visually by US public health service criteria

    12 month

  • Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria

    12 month

  • Restorations with surface roughness as assessed tactilely by US public health service criteria

    12 month

  • Restorations developed secondary caries as assessed visually by US public health service criteria

    12 month

Study Arms (2)

Suprinity

EXPERIMENTAL

Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH \& Co.KG- Germany) Zirconia reinforced lithium silicate PCRs

Other: Vita Suprinity

e.max

ACTIVE COMPARATOR

IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs

Other: IPS e.max

Interventions

Vita SuprinityOTHER

zirconia reinforced lithium silicate partial coverage restorations

Suprinity
IPS e.maxOTHER

lithium disilicate partial coverage restorations

e.max

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants:
  • Good oral hygiene, papillary bleeding index (PBI) \< 35%.
  • Positive patient acceptance to participate in the trial.
  • Teeth:
  • Carious class II or MOD lesions
  • Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • Normal occlusion
  • Single tooth restoration (no edentulous space that requires fixed prosthesis)

You may not qualify if:

  • Participants
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Bad oral hygiene
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or temporomandibular disorders.
  • Teeth:
  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Tooth hypersensitivity.
  • Rampant caries.
  • Non-vital or endodontically treated teeth.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine- Cairo University

Cairo, Egypt

Location

Related Publications (11)

  • Guess PC, Strub JR, Steinhart N, Wolkewitz M, Stappert CF. All-ceramic partial coverage restorations--midterm results of a 5-year prospective clinical splitmouth study. J Dent. 2009 Aug;37(8):627-37. doi: 10.1016/j.jdent.2009.04.006. Epub 2009 May 3.

    PMID: 19477570BACKGROUND

  • Stappert CF, Guess PC, Chitmongkolsuk S, Gerds T, Strub JR. All-ceramic partial coverage restorations on natural molars. Masticatory fatigue loading and fracture resistance. Am J Dent. 2007 Feb;20(1):21-6.

    PMID: 17380803BACKGROUND

  • 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.

    PMID: 18006051BACKGROUND

  • Rinke S, Pabel AK, Rodiger M, Ziebolz D. Chairside Fabrication of an All-Ceramic Partial Crown Using a Zirconia-Reinforced Lithium Silicate Ceramic. Case Rep Dent. 2016;2016:1354186. doi: 10.1155/2016/1354186. Epub 2016 Mar 6.

    PMID: 27042362BACKGROUND

  • McDonald A. Preparation guidelines for full and partial coverage ceramic restorations. Dent Update. 2001 Mar;28(2):84-90. doi: 10.12968/denu.2001.28.2.84.

    PMID: 11819962BACKGROUND

  • Signore A, Benedicenti S, Covani U, Ravera G. A 4- to 6-year retrospective clinical study of cracked teeth restored with bonded indirect resin composite onlays. Int J Prosthodont. 2007 Nov-Dec;20(6):609-16.

    PMID: 18069370BACKGROUND

  • 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

  • Stappert CF, Chitmongkolsuk S, Silva NR, Att W, Strub JR. Effect of mouth-motion fatigue and thermal cycling on the marginal accuracy of partial coverage restorations made of various dental materials. Dent Mater. 2008 Sep;24(9):1248-57. doi: 10.1016/j.dental.2008.02.005. Epub 2008 Apr 18.

    PMID: 18395785BACKGROUND

  • Murgueitio R, Bernal G. Three-year clinical follow-up of posterior teeth restored with leucite-reinforced ips empress onlays and partial veneer crowns. J Prosthodont. 2012 Jul;21(5):340-5. doi: 10.1111/j.1532-849X.2011.00837.x. Epub 2012 Feb 28.

    PMID: 22372380BACKGROUND

  • Kois DE, Isvilanonda V, Chaiyabutr Y, Kois JC. Evaluation of fracture resistance and failure risks of posterior partial coverage restorations. J Esthet Restor Dent. 2013 Apr;25(2):110-22. doi: 10.1111/jerd.12018. Epub 2013 Mar 19.

    PMID: 23617385BACKGROUND

  • Vogl V, Hiller KA, Buchalla W, Federlin M, Schmalz G. Controlled, prospective, randomized, clinical split-mouth evaluation of partial ceramic crowns luted with a new, universal adhesive system/resin cement: results after 18 months. Clin Oral Investig. 2016 Dec;20(9):2481-2492. doi: 10.1007/s00784-016-1779-2. Epub 2016 Mar 12.

    PMID: 26971352BACKGROUND

MeSH Terms

Interventions

VITA Suprinity

Study Officials

  • Hesham Katamish, PHD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split-mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 10, 2016

Study Start

May 1, 2017

Primary Completion

June 18, 2018

Study Completion

July 18, 2018

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

EG(1)