Straumann Roxolid Multi-Center Study

Not Applicable

Completed

Conditions: Jaw, Edentulous, Partially

Interventions: Device: Straumann Bone Level Implants, 3.3 mm implant diameter
Device: Straumann Bone Level Implants, 4.1 mm implant diameter

Registration Number: NCT01842958

Lead Sponsor: Institut Straumann AG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3.3 mm implant diameter	Straumann Bone Level Implants, 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
4.1 mm implant diameter	Straumann Bone Level Implants, 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

Primary Outcome Measures

Name	Time	Method
Mean Crestal Bone Level Change	Baseline (implant placement) and 12 months post loading	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.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	12 months post loading	Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain)
Implant Survival Rate	7 days, 25 days, 6 months post loading, and 12 months post loading	Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
Gingival Recession	6 months to 12 months post loading	Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters.
Additional Mean Crestal Bone Level Changes	Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading	Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post 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	Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)
Number of Participants With Adverse Events and Adverse Device Effects	Duration of the study from surgical visit to the 12 months post-loading visit	Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related").

Trial Locations

Locations (5): UCLA School of Dentistry
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Los Angeles, California, United States
Boston University, School of Dental Medicine
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Boston, Massachusetts, United States
New York University College of Dentistry
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New York, New York, United States
University of Washington
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Seattle, Washington, United States
Univeristy of Texas Health Science Center San Antonio
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San Antonio, Texas, United States