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Evaluation of a New Design of Crowns in the Posterior Teeth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02110550
Enrollment
40
Registered
2014-04-10
Start date
2014-05-31
Completion date
2015-10-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Broken Down Molars, IPS-emmax Crowns

Keywords

endocrown, marginal adaptation, anatomic form, retention loss, IPS.emmax crowns

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.

Interventions

OTHERIPS.emmax endocrown

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Marginal Adaptationat 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following applicationThe 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 Format 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following applicationThe 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

MeasureTime frameDescription
Change in the Retention Statusat 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following applicationRetention loss is considered when the crown becomes loose or mobile.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026