Straumann Roxolid Multi-Center Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled, Multi-center Clinical Study Evaluating the Crestal Bone Level Changes of Straumann BL Ø 3.3 mm NC SLActive RXD Implants Compared to Straumann BL Ø 4.1 mm RC SLActive RXD Implants for Single Tooth Replacement.

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Straumann Bone Level Implants, 4.1 mm implant diameter
* Device: Straumann Bone Level Implants, 3.3 mm implant diameter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4.1 mm implant diameter<br>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<br>* Straumann Bone Level Implants, 4.1 mm implant diameter<br>|
| Experimental: 3.3 mm implant diameter<br>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<br>* Straumann Bone Level Implants, 3.3 mm implant diameter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Mean Crestal Bone Level Changes | 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 | Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading | 
| Implant Success Rate | 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) | 25 days, 6 months post loading, and 12 months post loading | 
| Implant Survival Rate | Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up) | 7 days, 25 days, 6 months post loading, and 12 months post loading | 
| Gingival Recession | 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. | 6 months to 12 months post loading | 
| Number of Participants With Adverse Events and Adverse Device Effects | 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). | Duration of the study from surgical visit to the 12 months post-loading visit | 
| Subject Satisfaction | 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) | 12 months post loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implant