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

Sponsor
Institut Straumann AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01878331
Collaborator
(none)
49
Enrollment
1
Location
63
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Detailed 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)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    49 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2018
    Actual Study Completion Date :
    Sep 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Implant Survival [10 years following implant procedure date]

      This is a long term follow up extension study including evaluations at 5 and 10 years after the implant procedure from the core study. Implant survival will be assessed based on surviving implants for all patients at 10 years.

    Secondary Outcome Measures

    1. Crestal bone level change [5 and 10 years]

      The change in crestal bone level will be measured on standard x-rays taken at 5 and 10 years as per standard of care. An independent reviewer will evaluate all x-rays for the analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Frauke Müller Geneva Switzerland 1211

    Sponsors and Collaborators

    • Institut Straumann AG

    Investigators

    • Study Chair: Frauke Müller, Prof., University of Geneva
    • Principal Investigator: Bilal Al-Nawas, Prof., Klinikum der Johannes - Gutenberg - Universität Mainz
    • Principal Investigator: Eugenio Romeo, Prof., Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria
    • Principal Investigator: Joke Duyck, Prof., Department of Oral Health Sciences, Catholic University (KU) Leuven
    • Principal Investigator: Torsten E Reichert, Prof., Klinikum der Universität Regensburg
    • Principal Investigator: Alessandro Perucchi, Prof., Luzerner Kantonsspital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Straumann AG
    ClinicalTrials.gov Identifier:
    NCT01878331
    Other Study ID Numbers:
    • CR 01/13
    First Posted:
    Jun 14, 2013
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Jaw, Edentulous
    Mouth, Edentulous

    Study Results

    No Results Posted as of Jan 7, 2020