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

NCT01878331 | Completed

• 1 other identifier: CR 01/13
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Jaw, Edentulous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Crestal bone level change

  5 and 10 years

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Frauke Müller

Geneva, 1211, Switzerland

Location

Related Publications (2)

• Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti M, Srinivasan M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: Ten-year results from a double-blind, randomised controlled split-mouth core-trial. Clin Oral Implants Res. 2024 Jan;35(1):77-88. doi: 10.1111/clr.14199. Epub 2023 Nov 9.

  PMID: 37942666 DERIVED

• 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.

  PMID: 26458813 DERIVED

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

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

Study Officials

• Frauke Müller, Prof.

  University of Geneva

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: June 14, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)