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Marginal Fit of Porcelain Veneers After Finishing Prepared Surfaces With Ultrasonic Tips

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Ultrasonic tips
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Tooth preparation, Prosthodontics

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aesthetic requirement with no cracks and congenital loss of any incisors.
  • discolored teeth not responding to bleaching.

Exclusion Criteria:

  • evidence proximal caries ,
  • edge to edge occlusion
  • parafunctional habits
  • root canal treated teeth.

Sites / Locations

  • Department of Fixed Prosthodontics, University of Damsacus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultrasonic tips

Conventional

Arm Description

Prepared surfaces will be finished with ultrasonic tips

Prepared surfaces will be finished with ordinary burs

Outcomes

Primary Outcome Measures

Thickness of the light silicone layer encompassed between the abutment and the veneer
A light silicone material is going to be used to allow for measuring any gaps beneath the veneers. The measurement will be in micrometer using a microscope.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2016
Last Updated
March 11, 2016
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02683499
Brief Title
Marginal Fit of Porcelain Veneers After Finishing Prepared Surfaces With Ultrasonic Tips
Official Title
A Double-blind Split-mouth Randomized Clinical Trail Evaluating Marginal Fit of Porcelain Laminate Veneers Following Finishing the Prepared Surfaces With Ultrasonic Tips Compared to the Conventional Way
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to assess the marginal fit following preparation finishing with ultrasonic tips of porcelain veneers compared to the ordinary preparation using burs only. Two-hundred and forty crowns prepared to receive porcelain veneers (in a split-mouth design). On one side of the mouth, the prepared surfaces will be finished with ultrasonic tips. Marginal fit is measured by a 'cement replica technique'.
Detailed Description
All-ceramic restoration are increasing in daily routine treatments although remain less popular than metal-ceramic crowns especially as the cost of metal rises and aesthetic requested people increases The increased demand for aesthetic treatments has led to the widespread use of metal-free ceramics for conservative restorations. Whilst studies for clinical porcelain restorations clarifies satisfactory success rates describes the reasons for failure is due to advance the techniques and materials used in dental restorations. All-ceramic restorations failures are due to several reasons, such as restoration fractures, discoloration in marginal area, marginal misfits and secondary decays. However, secondary caries is the main failure mentioned by the studies, responsible for 21% of the suddenly crown replacements. The etiology of secondary caries is as classified to primary caries, with the involvement of the same cariogenic microorganisms. The place and spread where to invade of primary and secondary lesions are also similar, with secondary caries developing mainly in the gingival tooth interface of restored teeth. Different authors have mentioned different instrumentation to prepare teeth appropriately.Preparation may be applied using diamond burs attached to sonic devices or high-speed rotating instruments with diamond or tungsten carbide burs. The action of conventional high-speed instruments applied for tooth preparation has been widely researched as well as the adhesion strengths and marginal microleakage it produces. Some authors insisted that dental surface morphology of prepared teeth is influenced by the type of bur used for preparation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
Tooth preparation, Prosthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonic tips
Arm Type
Experimental
Arm Description
Prepared surfaces will be finished with ultrasonic tips
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Prepared surfaces will be finished with ordinary burs
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic tips
Intervention Description
These tips are going to be used to give the final shape of the prepared surfaces before taking the impression for the construction of the veneers.
Primary Outcome Measure Information:
Title
Thickness of the light silicone layer encompassed between the abutment and the veneer
Description
A light silicone material is going to be used to allow for measuring any gaps beneath the veneers. The measurement will be in micrometer using a microscope.
Time Frame
measurement will be made immediately (in the same day) of applying the constructed veneers onto the prepared dental surfaces

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aesthetic requirement with no cracks and congenital loss of any incisors. discolored teeth not responding to bleaching. Exclusion Criteria: evidence proximal caries , edge to edge occlusion parafunctional habits root canal treated teeth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Abdo, DDS
Organizational Affiliation
MSc student in Prosthodontics, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mirza Allaf, DDS MSc PhD
Organizational Affiliation
Associate Professor of Prosthodontics
Official's Role
Study Director
Facility Information:
Facility Name
Department of Fixed Prosthodontics, University of Damsacus
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19054303
Citation
Ayad MF. Effects of tooth preparation burs and luting cement types on the marginal fit of extracoronal restorations. J Prosthodont. 2009 Feb;18(2):145-51. doi: 10.1111/j.1532-849X.2008.00398.x. Epub 2008 Nov 18.
Results Reference
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PubMed Identifier
19643221
Citation
Ayad MF, Johnston WM, Rosenstiel SF. Influence of dental rotary instruments on the roughness and wettability of human dentin surfaces. J Prosthet Dent. 2009 Aug;102(2):81-8. doi: 10.1016/S0022-3913(09)60114-1.
Results Reference
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PubMed Identifier
21037189
Citation
Christensen RP, Ploeger BJ. A clinical comparison of zirconia, metal and alumina fixed-prosthesis frameworks veneered with layered or pressed ceramic: a three-year report. J Am Dent Assoc. 2010 Nov;141(11):1317-29. doi: 10.14219/jada.archive.2010.0076.
Results Reference
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PubMed Identifier
4555792
Citation
Eick JD, Johnson LN, Fromer JR, Good RJ, Neumann AW. Surface topography: its influence on wetting and adhesion in a dental adhesive system. J Dent Res. 1972 May-Jun;51(3):780-8. doi: 10.1177/00220345720510031401. No abstract available.
Results Reference
background
PubMed Identifier
2700463
Citation
Finger WJ, Manabe A, Alker B. Dentin surface roughness vs. bond strength of dentin adhesives. Dent Mater. 1989 Sep;5(5):319-23. doi: 10.1016/0109-5641(89)90123-1.
Results Reference
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PubMed Identifier
17262225
Citation
Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30. Erratum In: Clin Oral Investig. 2008 Mar;12(1):97.
Results Reference
background
PubMed Identifier
19544814
Citation
Lange RT, Pfeiffer P. Clinical evaluation of ceramic inlays compared to composite restorations. Oper Dent. 2009 May-Jun;34(3):263-72. doi: 10.2341/08-95.
Results Reference
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PubMed Identifier
3306618
Citation
Mowery AS Jr, Parker M, Davis EL. Dentin bonding: the effect of surface roughness on shear bond strength. Oper Dent. 1987 Summer;12(3):91-4. No abstract available.
Results Reference
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PubMed Identifier
2845071
Citation
Price RB, Sutow EJ. Micrographic and profilometric evaluation of the finish produced by diamond and tungsten carbide finishing burs on enamel and dentin. J Prosthet Dent. 1988 Sep;60(3):311-6. doi: 10.1016/0022-3913(88)90275-2. No abstract available.
Results Reference
background

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Marginal Fit of Porcelain Veneers After Finishing Prepared Surfaces With Ultrasonic Tips

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