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Straumann Roxolid Multi-Center Study

NCT01842958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-15

Study results available
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Summary

The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery and 12 months post-implant placement. The secondary objectives will assess differences in clinical outcomes between the test and control implants, including implant success and survival, gingival recession, subject satisfaction and additional early bone level measurements.

Conditions

  • Jaw, Edentulous, Partially

Interventions

DEVICE

Straumann Bone Level Implants, 4.1 mm implant diameter

Straumann Bone Level Implants, 4.1 mm implant diameter

DEVICE

Straumann Bone Level Implants, 3.3 mm implant diameter

Straumann Bone Level Implants, 3.3 mm implant diameter

Sponsors & Collaborators

  • Institut Straumann AG

    lead INDUSTRY

Principal Investigators

  • David L. Cochran, DDS, MS, PhD · University of Texas Health Science Center San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842958 on ClinicalTrials.gov