Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of Fracture Resistance and Color Changes of Laminate Veneer With Gull Wing Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03321474
Recruitment Status : Not yet recruiting
First Posted : October 25, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Zeinab Elshamy, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Patient with discolored anterior teeth and need conservative restoration treated with all ceramic esthetic laminate veneers. The Patient will be satisfied with restoration mimic the surrounding natural teeth, but conventional preparation shows approximately 60% of veneer failure in form of color change and nearly 67% Fractures of laminate veneers so the modified gull wing preparation is a significant factor affecting the final esthetic especially in discolored teeth and improve fracture resistance of the restoration.

Condition or disease Intervention/treatment Phase
Discolored Teeth Procedure: modified gull wing preparation Not Applicable

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Fracture Resistance and Color Changes of All Ceramic Laminate Veneers Prepared With Modified Gull Wing Versus Conventional Technique
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: modified gull wing preparation
Gullwing preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation
 Procedure: modified gull wing preparation

preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally.

The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

Other Name: dog leg ,dog-led -proximal extension preparation
Active Comparator: conventional preparation

In conventional preparation of veneer it circumvents the contact areas and extends palatally in the incisal third of the tooth only. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines placed facially to the proximal contacts

Gull wing (dog leg) preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. This preparation design helps to hide the restoration margin when viewed from an angle, especially in discoloration.

The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

 Procedure: modified gull wing preparation

preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally.

The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

Other Name: dog leg ,dog-led -proximal extension preparation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. fracture of restoration [ Time Frame: one year ]
    The fracture of the restoration of the two groups will be assessed using the modified United States public health service ( USPHS) criteria


Secondary Outcome Measures :
  1. color changed [ Time Frame: one year ]
    Secondary outcome : Color match Color changes of the two groups will be assessed using the modified United States public health service (USPHS) criteria


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria
  • age groups from 18-50-year-old
  • patients able to read and sign the informed consent.
  • patient without periodontal diseases
  • Patients indicated for laminate veneers.
  • patients Willing to return for follow -up
  • Exclusion Criteria
  • Patients with poor oral hygiene
  • patients with endodontic ally treated teeth
  • patients with Psychiatric problems
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321474


Contacts
Layout table for location contacts
Contact: zeinab saeed Elshamy, MDS 01125195692 zeinab.alshamy@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Duzyol M, Duzyol E, Seven N. Fracture Resistance of Laminate Veneers Made with Different Cutting and Preparation Techniques. 2016;4(3):42-48. doi:10.12691/ijdsr-4-3-3.

Layout table for additonal information
Responsible Party: Zeinab Elshamy, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03321474     History of Changes
Other Study ID Numbers: CEBD-CU-2017-10-24
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases