The Clinical Performance of Inlay Zirconia Bridges

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.

Study Overview

• Status: Completed
• Conditions: Dental Crowns
• Intervention / Treatment: Procedure: Glaze layer; Procedure: E-max Press layer

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Zirconia and E-max Press; The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
Experimental: Zirconia and E-max Press and Glaze; 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 a glaze layer to improve adhesion.	Procedure: Glaze layer; A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
Experimental: Zirconia and E-max Press twice; 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 an E-max Press layer to improve adhesion.	Procedure: E-max Press layer; A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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.	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in the Retention Status	The resistance of a prosthesis to displacement will be measured.	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sensitivity	The presence of any spontaneous or stimulated pain will be assumed.	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in Patients' Satisfaction	A questionnaire will be used to detect the level of satisfaction regarding function and shade	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in Shade	The shade is going to be determined using Vita(R) shade guide.	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Mansour Abo Alkasab, DDS MSc, PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria; Study Director: Jihad Abo Nassar, DDS MSc PhD, Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 9, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-FixPro-02-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO