Recruitment

Recruitment Status
Terminated

Inclusion Criteria

The subject is healthy and compliant with good oral hygiene
No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
...
The subject is healthy and compliant with good oral hygiene
No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
The subject should be available for the 5-year term of the investigation.
The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
Obtained informed consent from the subject prior to the study.
The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.

Exclusion Criteria

The subject is not able to give her/his informed consent to participate.
An existing condition where acceptable retention of the restoration is impossible to attain
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.
...
The subject is not able to give her/his informed consent to participate.
An existing condition where acceptable retention of the restoration is impossible to attain
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.
Alcohol or drug abuse as noted in patient records or in patient history.
Pathologic pocket formation of 4 mm or greater around the tooth to be restored
Mobility greater than grade 1 of the tooth to be restored.
Health conditions, which do not permit the restorative procedure
Severe bruxism or other destructive habits
Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).

Summary

Conditions
Posterior Bridge Restoration
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Inclusion Criteria

The subject is healthy and compliant with good oral hygiene
No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
...
The subject is healthy and compliant with good oral hygiene
No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
The subject should be available for the 5-year term of the investigation.
The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
Obtained informed consent from the subject prior to the study.
The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.

Exclusion Criteria

The subject is not able to give her/his informed consent to participate.
An existing condition where acceptable retention of the restoration is impossible to attain
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.
...
The subject is not able to give her/his informed consent to participate.
An existing condition where acceptable retention of the restoration is impossible to attain
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.
Alcohol or drug abuse as noted in patient records or in patient history.
Pathologic pocket formation of 4 mm or greater around the tooth to be restored
Mobility greater than grade 1 of the tooth to be restored.
Health conditions, which do not permit the restorative procedure
Severe bruxism or other destructive habits
Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).

Tracking Information

NCT #
NCT02197312
Collaborators
Not Provided
Investigators
Not Provided