Clinical trial NCT01878331: Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaw, Edentulous
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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

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)

Eligibility 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

Primary outcomes:
measure: Implant Survival
timeFrame: 10 years following implant procedure date
Secondary outcomes:
measure: Crestal bone level change
timeFrame: 5 and 10 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Frauke Müller
Study officials:
affiliation: University of Geneva
name: Frauke Müller, Prof.
role: STUDY_CHAIR
affiliation: Klinikum der Johannes - Gutenberg - Universität Mainz
name: Bilal Al-Nawas, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria
name: Eugenio Romeo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oral Health Sciences, Catholic University (KU) Leuven
name: Joke Duyck, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Universität Regensburg
name: Torsten E Reichert, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Luzerner Kantonsspital
name: Alessandro Perucchi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.