Recruitment

Recruitment Status
Terminated

Inclusion Criteria

The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
The subject is healthy and compliant with good oral hygiene
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
...
The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
The subject is healthy and compliant with good oral hygiene
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
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.
Obtained informed consent from the subject prior to the study.

Exclusion Criteria

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

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 shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
The subject is healthy and compliant with good oral hygiene
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
...
The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
The subject is healthy and compliant with good oral hygiene
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
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.
Obtained informed consent from the subject prior to the study.

Exclusion Criteria

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

Tracking Information

NCT #
NCT02197312
Collaborators
Not Provided
Investigators
Not Provided
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