The Clinical Performance of Inlay Zirconia Bridges

Not Applicable

Completed

• Conditions: Dental Crowns
• Interventions: Procedure: E-max Press layer; Procedure: Glaze layer

• Registration Number: NCT02995876
• Lead Sponsor: Damascus University

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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2018-01-15
• Study Completion: 2018-08-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-09
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zirconia and E-max Press twice	E-max Press layer	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.
Zirconia and E-max Press and Glaze	Glaze layer	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.

Primary Outcome Measures

Name	Time	Method
Change in marginal fit	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application	To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
Change in the Retention Status	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application	The resistance of a prosthesis to displacement will be measured.
Change in Material Integrity	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application	To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.

Secondary Outcome Measures

Name	Time	Method
Change in Marginal Color Matching	Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application	Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays

Trial Locations

Locations (1)

Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria; 🇸🇾 Damascus, Syrian Arab Republic