- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02683499
Marginal Fit of Porcelain Veneers After Finishing Prepared Surfaces With Ultrasonic Tips
March 11, 2016 updated by: Damascus University
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
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'.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Damascus, Syrian Arab Republic, DM20AM18
- Department of Fixed Prosthodontics, University of Damsacus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ultrasonic tips
Prepared surfaces will be finished with ultrasonic tips
|
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.
|
|
NO_INTERVENTION: Conventional
Prepared surfaces will be finished with ordinary burs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thickness of the light silicone layer encompassed between the abutment and the veneer
Time Frame: measurement will be made immediately (in the same day) of applying the constructed veneers onto the prepared dental surfaces
|
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.
|
measurement will be made immediately (in the same day) of applying the constructed veneers onto the prepared dental surfaces
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anas Abdo, DDS, MSc student in Prosthodontics, University of Damascus Dental School
- Study Director: Mirza Allaf, DDS MSc PhD, Associate Professor of Prosthodontics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
February 6, 2016
First Submitted That Met QC Criteria
February 16, 2016
First Posted (ESTIMATE)
February 17, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
March 15, 2016
Last Update Submitted That Met QC Criteria
March 11, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-FixPro-01-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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