Overview

This trial is active, not recruiting.

Condition jaw, edentulous
Sponsor Institut Straumann AG
Start date June 2013
End date September 2018
Trial size 75 participants
Trial identifier NCT01878331, CR 01/13

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
Implant Survival
time frame: 10 years following implant procedure date

Secondary Outcomes

Measure
Crestal bone level change
time frame: 5 and 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles
Principal investigator Bilal Al-Nawas, Prof.
Description 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)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Institut Straumann AG.