Straumann Roxolid Multi-Center Study

NCT ID: NCT01842958

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed Description

This is a randomized, controlled, multi-center clinical study. The total study duration for each patient should be 12 ± 1 months.

Straumann Bone Level implants will be placed in the pre-molar or anterior region of the mandible or maxilla for single tooth replacement, followed by provisional prosthetic loading after 25 ± 4 days and by final prosthetic loading 6 ± 1 months after implant loading.

In total 6 visits per patient are scheduled in this study. Bone level changes, implant success and survival, gingival recession, subject satisfaction and adverse events (AEs) will be assessed.

The study devices are CE-(Conformité Européenne, meaning European Conformity) marked products. Straumann Bone Level implants Ø 3.3 mm NC SLActive Roxolid and Straumann Bone Level Ø 4.1 mm RC SLActive implants.

Five centers in USA will participate.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4.1 mm implant diameter

Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region

Group Type: ACTIVE_COMPARATOR

Straumann Bone Level Implants, 4.1 mm implant diameter

Intervention Type: DEVICE

Straumann Bone Level Implants, 4.1 mm implant diameter

3.3 mm implant diameter

Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region

Group Type: EXPERIMENTAL

Straumann Bone Level Implants, 3.3 mm implant diameter

Intervention Type: DEVICE

Straumann Bone Level Implants, 3.3 mm implant diameter

Interventions

Straumann Bone Level Implants, 4.1 mm implant diameter

Straumann Bone Level Implants, 4.1 mm implant diameter

Intervention Type: DEVICE

Straumann Bone Level Implants, 3.3 mm implant diameter

Straumann Bone Level Implants, 3.3 mm implant diameter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have voluntarily signed the informed consent form
• Subjects must be males or females who are a minimum of 20 years of age
• Subjects must have a single tooth gap in the pre-molar or anterior region of the mandible or maxilla (ADA tooth positions 4-13 and 20-29; FDI tooth positions 11-15, 21-25, 31-35, and 41-45)
• Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
• Subjects must have a full mouth plaque score ≤ 25%, according to O'Leary, at the time of screening
• Subjects must have adequate bone to encapsulate the implant and allow placement of an Ø 4.1 mm Bone Level Implant.
• Adequate bone height of at least 1 mm longer than the length of the study implant
• Subjects must have substantially healed (at least 16 weeks after tooth extraction) extraction sockets
• Subjects must be committed to the study and the required follow-up visits
• Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria

• Subjects with a systemic disease that would preclude dental implant surgery (e.g. serious internal medical problems, disorders of bone metabolism, uncontrolled bleeding disorders, weakened immune system, illness requiring periodic use of steroids, uncontrollable endocrine disorders, uncontrolled diabetes)
• Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia)
• Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
• Subjects with a history of local irradiation therapy in the head/neck area
• Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
• Subjects receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
• Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction
• Subjects with existing implants in the adjacent positions to the planned implant site
• Subjects requiring bone augmentation or socket grafting within 6 months prior to surgery
• Subjects requiring more than minimal simultaneous augmentation for minimal buccal dehiscence defects (defect cannot be greater than 3mm in height)
• Subjects with inadequate oral hygiene or who are unmotivated for adequate home care
• Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
• Subjects who are pregnant or intending to become pregnant during the duration of the study
• Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco
• Subjects who abuse alcohol or drugs
• Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
• Subjects with 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 or unreliability

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L. Cochran, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

UCLA School of Dentistry

Los Angeles, California, United States

Boston University, School of Dental Medicine

Boston, Massachusetts, United States

New York University College of Dentistry

New York, New York, United States

Univeristy of Texas Health Science Center San Antonio

San Antonio, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

CR 10/09

Identifier Type: -

Identifier Source: org_study_id