Clinical trial NCT02110550: Evaluation of a New Design of Crowns in the Posterior Teeth
Official title: Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Broken Down Molars
IPS-emmax Crowns
Keywords: endocrown
marginal adaptation
anatomic form
retention loss
IPS.emmax crowns
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Inclusion criteria of molars:

* 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

Primary outcomes:
measure: Change in Marginal Adaptation
timeFrame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
measure: Change in the Anatomic Form
timeFrame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
Secondary outcomes:
measure: Change in the Retention Status
timeFrame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Fixed Prosthodontics, University of Damsacus
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus Dental School
Study officials:
affiliation: University of Damascus Dental School
name: Rana Dallool, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.