NCT01835821

Brief Summary

This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

5.5 years

First QC Date

April 5, 2013

Last Update Submit

July 4, 2014

Conditions

SuccessSurvivalCDA Index

Keywords

zirconiacrownIPS e.max CAD

Outcome Measures

Primary Outcomes (1)

  • success of Porcelain-fused and IPS e.Max CAD Crowns

    A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.

    5 years

Secondary Outcomes (1)

  • survival of Porcelain-fused and IPS e.Max CAD Crowns

    5 years

Other Outcomes (1)

  • CDA index

    5 years

Study Arms (1)

prosthesis

EXPERIMENTAL

NobelProcera™ Crown shaded zirconia: The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory

Device: prosthetic crowns

Interventions

prosthetic crownsDEVICE

prosthetic crowns

prosthesis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is healthy and compliant with good oral hygiene.
  • The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
  • The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
  • Obtained informed consent from the subject.
  • No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
  • Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
  • The subject is available for the 5-year term of the investigation.

You may not qualify if:

  • The subject is not able to give her/his informed consent to participate.
  • Alcohol or drug abuse as noted in patient records or in patient history.
  • Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
  • An existing condition where acceptable retention of the restoration is impossible to attain
  • Mobility of the tooth to be restored.
  • Pathologic pocket formation of 4 mm or greater around the tooth to be restored.
  • Severe bruxism or other destructive habits.
  • Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
  • Health conditions, which do not permit the restorative procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy

Siena, SI, 53100, Italy

Location

Related Publications (1)

  • Cagidiaco EF, Grandini S, Goracci C, Joda T. A pilot trial on lithium disilicate partial crowns using a novel prosthodontic functional index for teeth (FIT). BMC Oral Health. 2019 Dec 9;19(1):276. doi: 10.1186/s12903-019-0957-4.

    PMID: 31818278DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 19, 2013

Study Start

March 1, 2010

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

IT(1)