NCT02683499

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

February 6, 2016

Last Update Submit

March 11, 2016

Conditions

Keywords

Tooth preparationProsthodontics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ultrasonic tips

EXPERIMENTAL

Prepared surfaces will be finished with ultrasonic tips

Procedure: Ultrasonic tips

Conventional

NO INTERVENTION

Prepared surfaces will be finished with ordinary burs

Interventions

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.

Ultrasonic tips

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Fixed Prosthodontics, University of Damsacus

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (9)

  • 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.

    PMID: 19054303BACKGROUND
  • 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.

    PMID: 19643221BACKGROUND
  • 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.

    PMID: 21037189BACKGROUND
  • 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.

    PMID: 4555792BACKGROUND
  • 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.

    PMID: 2700463BACKGROUND
  • 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.

    PMID: 17262225BACKGROUND
  • 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.

    PMID: 19544814BACKGROUND
  • 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.

    PMID: 3306618BACKGROUND
  • 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.

    PMID: 2845071BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Anas Abdo, DDS

    MSc student in Prosthodontics, University of Damascus Dental School

    PRINCIPAL INVESTIGATOR
  • Mirza Allaf, DDS MSc PhD

    Associate Professor of Prosthodontics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2016

First Posted

February 17, 2016

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations