Straumann Roxolid Multi-Center Study

NCT01842958 | Completed Results

• 1 other identifier: CR 10/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Jaw, Edentulous, Partially

Keywords

Dental Implant

Outcome Measures

Primary Outcomes (1)

• Mean Crestal Bone Level Change

  Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.

  Baseline (implant placement) and 12 months post loading

Secondary Outcomes (6)

• Additional Mean Crestal Bone Level Changes

  Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading

• Implant Success Rate

  25 days, 6 months post loading, and 12 months post loading

• Implant Survival Rate

  7 days, 25 days, 6 months post loading, and 12 months post loading

• Gingival Recession

  6 months to 12 months post loading

• Number of Participants With Adverse Events and Adverse Device Effects

  Duration of the study from surgical visit to the 12 months post-loading visit

Study Arms (2)

4.1 mm implant diameter

ACTIVE COMPARATOR

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

Device: Straumann Bone Level Implants, 4.1 mm implant diameter

3.3 mm implant diameter

EXPERIMENTAL

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

Device: Straumann Bone Level Implants, 3.3 mm implant diameter

Interventions

Straumann Bone Level Implants, 4.1 mm implant diameter DEVICE

Straumann Bone Level Implants, 4.1 mm implant diameter

4.1 mm implant diameter

Straumann Bone Level Implants, 3.3 mm implant diameter DEVICE

Straumann Bone Level Implants, 3.3 mm implant diameter

3.3 mm implant diameter

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (5)

UCLA School of Dentistry

Los Angeles, California, 90095-1668, United States

Location

Boston University, School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

New York University College of Dentistry

New York, New York, 10019-5404, United States

Location

Univeristy of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

University of Washington

Seattle, Washington, 98195-7444, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kelly Jork
• Organization: Straumann USA, LLC

kelly.jork@straumann.com

978-747-2533

Study Officials

• David L. Cochran, DDS, MS, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 30, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 15, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)