Evaluation of a New Design of Crowns in the Posterior Teeth
NCT ID: NCT02110550
Last Updated: 2015-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-05-31
2015-10-31
Brief Summary
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Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria.
Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio).
Intervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.
Main outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period.
Assessor blinding will be employed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IPS.emmax crown
No interventions assigned to this group
IPS.emmax endocrown
Patients with excessively undermined and endodontically treated molars will receive the IPS.emmax endocrown as the restoration of choice.
IPS.emmax endocrown
Interventions
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IPS.emmax endocrown
Eligibility Criteria
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Inclusion Criteria
* Good oral hygiene
* Gingival index (GI) equal 0
* Plaque index (PI) equal 0 or 1
* Primary acceptation and commitment to the trail
* Two remaining axial walls at least.
* 0.5 mm above the gingival line at least for damaged axial walls.
* Good endodontic treatment and apical seal
* First and second upper and lower molars only.
* Against teeth could be natural or crowned.
Exclusion Criteria
* Bruxism
* Periodontitis
* Gingival hyperplasia
20 Years
60 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Rana Dallool, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Damascus Dental School
Locations
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Department of Fixed Prosthodontics, University of Damsacus
Damascus, Rif-dimashq Governorate, Syria
University of Damascus Dental School
Damascus, Rif-dimashq Governorate, Syria
Countries
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References
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Bernhart J, Brauning A, Altenburger MJ, Wrbas KT. Cerec3D endocrowns--two-year clinical examination of CAD/CAM crowns for restoring endodontically treated molars. Int J Comput Dent. 2010;13(2):141-54. English, German.
Biacchi GR, Basting RT. Comparison of fracture strength of endocrowns and glass fiber post-retained conventional crowns. Oper Dent. 2012 Mar-Apr;37(2):130-6. doi: 10.2341/11-105-L. Epub 2011 Sep 26.
Bindl A, Mormann WH. Clinical evaluation of adhesively placed Cerec endo-crowns after 2 years--preliminary results. J Adhes Dent. 1999 Autumn;1(3):255-65.
Fischer H, Marx R. Fracture toughness of dental ceramics: comparison of bending and indentation method. Dent Mater. 2002 Jan;18(1):12-9. doi: 10.1016/s0109-5641(01)00005-7.
Other Identifiers
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UDDS-FixPro-01-2014
Identifier Type: -
Identifier Source: org_study_id
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