Clinical trial NCT01842958: Straumann Roxolid Multi-Center Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: Dental Implant
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Crestal Bone Level Change
timeFrame: Baseline (implant placement) and 12 months post loading
Secondary outcomes:
measure: Additional Mean Crestal Bone Level Changes
timeFrame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
measure: Implant Success Rate
timeFrame: 25 days, 6 months post loading, and 12 months post loading
measure: Implant Survival Rate
timeFrame: 7 days, 25 days, 6 months post loading, and 12 months post loading
measure: Gingival Recession
timeFrame: 6 months to 12 months post loading
measure: Number of Participants With Adverse Events and Adverse Device Effects
timeFrame: Duration of the study from surgical visit to the 12 months post-loading visit
measure: Subject Satisfaction
timeFrame: 12 months post loading
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Dentistry
state: California
city: Boston
country: United States
facility: Boston University, School of Dental Medicine
state: Massachusetts
city: New York
country: United States
facility: New York University College of Dentistry
state: New York
city: San Antonio
country: United States
facility: Univeristy of Texas Health Science Center San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: David L. Cochran, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: