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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02683499
Other study ID # UDDS-FixPro-01-2016
Secondary ID
Status Completed
Phase N/A
First received February 6, 2016
Last updated March 11, 2016
Start date April 2015
Est. completion date March 2016

Study information

Verified date March 2016
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority Syria: Ministry of Higher Education
Study type Interventional

Clinical Trial 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'.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date March 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Syrian Arab Republic Department of Fixed Prosthodontics, University of Damsacus Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View Citation

Finger WJ, Manabe A, Alker B. Dentin surface roughness vs. bond strength of dentin adhesives. Dent Mater. 1989 Sep;5(5):319-23. — View Citation

Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör 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. Epub 2007 Jan 30. Review. Erratum in: Clin Oral Investig. 2008 Mar;12(1):97. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. measurement will be made immediately (in the same day) of applying the constructed veneers onto the prepared dental surfaces No
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