Evaluation of a New Design of Crowns in the Posterior Teeth

NCT ID: NCT02110550

Last Updated: 2015-10-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-10-31

Brief Summary

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Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns .

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.

Detailed Description

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Conditions

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Broken Down Molars IPS-emmax Crowns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IPS.emmax crown

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

IPS.emmax endocrown

Intervention Type OTHER

Interventions

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IPS.emmax endocrown

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients between 20 to 60 years old
* 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

* Patients with an open bite or cross bite.
* Bruxism
* Periodontitis
* Gingival hyperplasia
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

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.

Reference Type BACKGROUND
PMID: 20648740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21942234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11725673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11740960 (View on PubMed)

Other Identifiers

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UDDS-FixPro-01-2014

Identifier Type: -

Identifier Source: org_study_id

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