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Partial Coverage RestorationNCT02861729

Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns

A study testing Vita Suprinity and IPS e.max in people with Partial Coverage Restoration, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Partial Coverage Restoration
What is being tested?
Vita Suprinity and IPS e.max
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
1 May 2017to 18 Jul 2018
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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Participants
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Bad oral hygiene
  • Heavy smoking.
Show all 17Show fewer
  • 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.
  • Sever periodontal affection.
  • Tooth mobility

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Oral and Dental Medicine- Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial

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.

Read the detailed description

This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH \& Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.

Being tested
Vita Suprinity, IPS e.max
Keywords
Partial coverage restoration, Crown, Posterior teeth, All ceramic, Zirconia reinforced lithium silicate, Lithium disilicate, CAD/CAM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vita SuprinityOther

    zirconia reinforced lithium silicate partial coverage restorations

  • IPS e.maxOther

    lithium disilicate partial coverage restorations

Study groups in NCT02861729
Study groupRoleWhat they receive
SuprinityExperimentalVita Suprinity® (VITA Zahnfabrik H. Rauter GmbH \& Co.KG- Germany) Zirconia reinforced lithium silicate PCRs
Receives: Other: Vita Suprinity
e.maxActive comparatorIPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs
Receives: Other: IPS e.max

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 month

Secondary outcomes (5)

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

    restorations with visually detectable margin, catch or penetration of explorer at baseline or a change from baseline on visual analogue scale at 12 month

    Measured: 12 month

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

    restorations with visually detectable discoloration along margin at baseline or a change from baseline on visual analogue scale at 12 month

    Measured: 12 month

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

    restorations with visually detectable color mismatch with adjacent teeth at baseline or a change from baseline on visual analogue scale at 12 month

    Measured: 12 month

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

    restorations with tactilely detectable rough surface at baseline or a change from baseline on visual analogue scale at 12 month

    Measured: 12 month

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

    restorations with visually detectable secondary caries at baseline or a change from baseline on visual analogue scale at 12 month

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2016 (estimated)
  2. Study start1 May 2017
  3. Primary completion18 Jun 2018
  4. Study completion18 Jul 2018

Resources

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 design
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02861729
Sponsor's protocol ID
CEBD-CU-2016-08-177
Status last verified
Feb 2019
First submitted
4 Aug 2016
Last updated
6 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19477570

  • 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.

    PubMed 17380803

  • 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.

    PubMed 18006051

  • 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.

    PubMed 27042362

  • 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.

    PubMed 11819962

  • 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.

    PubMed 18069370

  • 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.

    PubMed 12186346

  • 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.

    PubMed 18395785

  • 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.

    PubMed 22372380

  • 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.

    PubMed 23617385

  • 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.

    PubMed 26971352

Questions about this trial

What is this clinical trial studying?

A study testing Vita Suprinity and IPS e.max in people with Partial Coverage Restoration, run by Cairo University at 1 site in Egypt.

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 17 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: finished, as of the sponsor's last update on 6 Feb 2019. 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: 12 month). 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 NCT02861729, which also lists 11 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 6 Feb 2019.

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