Completed

NCT Number: NCT02110550

Evaluation of a New Design of Crowns in the Posterior Teeth

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Broken Down Molars IPS-emmax Crowns

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Fixed Prosthodontics, University of Damsacus, Damascus, Rif-dimashq Governorate, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPS.emmax endocrown

Other

Primary outcomes

Change in Marginal Adaptation

Time frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application

The presence of marginal adaptation means that the restoration margins cannot be distinguished, the probe cannot find a step between the margins and the surrounding tissue, and no discoloration visible.
Change in the Anatomic Form

Time frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application

The anatomic form is considered satisfactory when the crown has a correct contour with tight proximal contact, no worn facets on restorations and no worn facets on opposing teeth.

Secondary outcomes

Change in the Retention Status

Time frame: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application

Retention loss is considered when the crown becomes loose or mobile.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 10, 2014
Registry last updated: Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.