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Dental CrownsNCT02995876

The Clinical Performance of Inlay Zirconia Bridges

A study testing Glaze layer and E-max Press layer in people with Dental Crowns, run by Damascus University at 1 site in Syria.

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

When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Dental Crowns
What is being tested?
Glaze layer and E-max Press layer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSyria
Study dates
Jun 2016to 15 Aug 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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Good oral hygiene
  • Low susceptibility to caries
  • Parallel alignment of abutment teeth
  • Immobility of the abutment teeth
  • Minimum height of abutment teeth ≥ 5 mm (connector thickness)
  • Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or 12 mm (width of molar)

Who cannot join

  • Severe para-functional habits.
  • Short clinical crowns (<5 mm)
  • Extensive defects of the clinical crown,
  • Loosening of teeth because of factors related to the periodontal tissues.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

    Damascus, DM20AM18

Other trials in Syria

About this study

Official title: The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs

When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. The development use of zirconia technology and all-ceramic systems has opened the potential for fabrication inlays zirconia bridges with durability and good aesthetics.

The purpose of this study is to clinically evaluate the placement of inlay bridge made of a Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive approach in the replacement of a single missing tooth.

Read the detailed description

This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with three designs in the replacement process of one single tooth (i.e. a missing premolar or molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press.

The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with glaze layer to improve the adhesion.

The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with a layer of e-max ceramic press to improve the adhesion.

Conditions
Dental Crowns
Being tested
Glaze layer, E-max Press layer

What participants receive

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

  • Glaze layerProcedure or surgery

    A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion

  • E-max Press layerProcedure or surgery

    A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

Study groups in NCT02995876
Study groupRoleWhat they receive
Zirconia and E-max PressNo interventionThe first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
Zirconia and E-max Press and GlazeExperimentalThe second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.
Receives: Procedure: Glaze layer
Zirconia and E-max Press twiceExperimentalThe third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.
Receives: Procedure: E-max Press layer

What is being measured

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

  1. Change in marginal fit

    To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.

    Measured: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

  2. Change in Material Integrity

    To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.

    Measured: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

  3. Change in the Retention Status

    The resistance of a prosthesis to displacement will be measured.

    Measured: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Secondary outcomes (1)

  1. Change in Marginal Color Matching

    Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays

    Measured: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Timeline

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

  1. First posted19 Dec 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion15 Jan 2018
  4. Study completion15 Aug 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
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995876
Sponsor's protocol ID
UDDS-FixPro-02-2016
Status last verified
Sep 2018
First submitted
14 Dec 2016
Last updated
11 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.

    PubMed 19407162

  • Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.

    PubMed 21594233

  • Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.

    PubMed 17165297

  • Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.

    PubMed 17052467

  • Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.

    PubMed 25862408

  • Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.

    PubMed 22166107

  • Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.

    PubMed 26561926

  • Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.

    PubMed 21736862

Questions about this trial

What is this clinical trial studying?

A study testing Glaze layer and E-max Press layer in people with Dental Crowns, run by Damascus University at 1 site in Syria.

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 6 inclusion and 4 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 11 Sep 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 Syria. 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?

Change in marginal fit (time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application). The study lists 3 primary outcomes in all. 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 NCT02995876, which also lists 8 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 11 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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