The Clinical Performance of Inlay Zirconia Bridges

NCT02995876 | Completed DMC

• 1 other identifier: UDDS-FixPro-02-2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Crowns

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Marginal Color Matching

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

Other Outcomes (3)

• Change in Sensitivity

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

• Change in Patients' Satisfaction

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

• Change in Shade

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

Study Arms (3)

Zirconia and E-max Press

NO INTERVENTION

The 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 Glaze

EXPERIMENTAL

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

Zirconia and E-max Press twice

EXPERIMENTAL

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

Interventions

Glaze layer PROCEDURE

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

Zirconia and E-max Press and Glaze

E-max Press layer PROCEDURE

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

Zirconia and E-max Press twice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, DM20AM18, Syria

Location

Related Publications (8)

• 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.

  PMID: 19407162 BACKGROUND

• 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.

  PMID: 21594233 BACKGROUND

• 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.

  PMID: 17165297 BACKGROUND

• 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.

  PMID: 17052467 BACKGROUND

• 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.

  PMID: 25862408 BACKGROUND

• 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.

  PMID: 22166107 BACKGROUND

• 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.

  PMID: 26561926 BACKGROUND

• 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.

  PMID: 21736862 RESULT

Study Officials

• Mansour Abo Alkasab, DDS MSc

  PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Jihad Abo Nassar, DDS MSc PhD

  Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: June 1, 2016
• Primary Completion: January 15, 2018
• Study Completion: August 15, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)