Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-09-30

Brief Summary

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Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Patients will not receive an investigational treatment in this study. Patients will be followed at 5 to 10 years from the date of the original implant loading

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Detailed Description

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The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years.

The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV:

* Implant survival
* Implant success according to Buser et al. (1990)
* Crestal bone level change measured by Orthopantomogram (OPT)
* Soft tissue health
* Clinical measurements
* Prosthetic parts assessments: Success and maintenance
* Oral Health Related Quality of Life (OHRQoL)
* Product Safety (Adverse events and device deficiencies)

Conditions

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Jaw, Edentulous

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Roxolid

Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant.

No interventions assigned to this group

SLActive

Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects must have voluntarily signed the informed consent form
* Patients must be committed to participate in the study until the ten year follow-up examinations
* Subjects must have received treatment in the CR 04/07 core study
* Subjects must have completed 3 year visit of core study

Exclusion Criteria

* Physical handicaps that would interfere with the ability to perform adequate oral hygiene or attend follow up visits
* Use of any investigational drug or device during the study
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No