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

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

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

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Frauke Müller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival	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.	10 years following implant procedure date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal bone level change	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.	5 and 10 years

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti R, Schimmel M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial. BMC Oral Health. 2015 Oct 12;15(1):123. doi: 10.1186/s12903-015-0107-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: CR 01/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO