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NCT Number: NCT01878331

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

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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Key information

Conditions

Jaw, Edentulous Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Frauke Müller

Geneva, 1211, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implant Survival

    Time frame: 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 outcomes

  1. Crestal bone level change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Straumann AG

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2013
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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