The Clinical Performance of Inlay Zirconia Bridges

Dental Crowns Clinical Trial

Official title:

The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995876
• Other study ID #: UDDS-FixPro-02-2016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: September 2018
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Crowns

Intervention

Procedure:
• Glaze layer
A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
• E-max Press layer
A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (8)

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. — View Citation

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. — View Citation

Cura C, Özcan 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sanli S, Çömlekoglu MD, Çömlekoglu 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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