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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT01878331
First received: April 29, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Patients with a 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

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 additional outcome parameters will be evaluated after 5 and 10 years post loading for the two different implant types Bone Level, Ø 3.3 mm, Titan Zircon vs. Bone Level, Ø 3.3 mm, Titan Grade 4):

  • Implant Survival
  • Implant success (according to Buser, 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)

Condition
Patients With Edentulous Mandibles

Study Type: Observational
Study Design: 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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Implant Survival [ Time Frame: 10 years following implant procedure date ] [ Designated as safety issue: No ]
    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:
  • Crestal bone level change [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: June 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Male or female patient ≥ 18 years of age who were provided with an implant supported over-denture in the mandible in the course of the core study (CR 04/07).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878331

Locations
Switzerland
Frauke Müller
Geneva, Switzerland, 1211
Sponsors and Collaborators
Institut Straumann AG
Investigators
Study Chair: Frauke Müller, PhD University of Geneva
Principal Investigator: Bilal Al-Nawas, PhD Klinikum der Johannes - Gutenberg - Universität Mainz
Principal Investigator: Eugenio Romeo, PhD Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria
Principal Investigator: Joke Duyck, PhD Department of Oral Health Sciences, Catholic University (KU) Leuven
Principal Investigator: Torsten E Reichert, PhD Klinikum der Universität Regensburg
Principal Investigator: Alessandro Perucchi, DMD Luzerner Kantonsspital
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT01878331     History of Changes
Other Study ID Numbers: CR 01/13
Study First Received: April 29, 2013
Last Updated: June 3, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission
Belgium: Ethics Committee
Italy: Ethics Committee

Keywords provided by Institut Straumann AG:
Edentulous mandibles

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 20, 2014