Clinical trial NCT02569671: Bone Level Tapered Multi-Center Study
Official title: Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Keywords: Dental Implants, Single-Tooth
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).

Detailed description: The primary objective is to demonstrate that the change in mean peri-implant marginal bone level changes (mesial and distal) from loading to 12 months post-loading of the test treatment will not be worse than the control treatments.

The secondary objectives of the study are to assess differences in clinical and radiographic outcomes between the test and control treatments at 12 months post-loading by looking at implant success and survival, buccal bone dimensional changes, implant stability, soft tissue changes, subject satisfaction, and adverse events.

An additional objective is to assess long-term differences in clinical and radiographic outcomes, as measured in the primary and secondary objectives, over the span of two, three, four, and five years.

Eligibility criteria: Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent form before any study related procedures
* Subjects must be males or females who are a minimum of 18 years of age
* Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
* Implants must be placed either immediately in an extraction socket or placed in a healed site (greater than 4 months healing) which has not been previously grafted.
* Planned site for implant must have a natural tooth both mesially and distally in the adjacent tooth positions
* Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
* There must be sufficient bone at the implant site to achieve primary stability
* 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
* Subjects with any contraindications for oral surgical procedures
* 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
* Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
* 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: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
Secondary outcomes:
measure: Implant success
timeFrame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
measure: Implant survival
timeFrame: Measured at 10 days post-surgery, 8 weeks post-surgery, 10-12 weeks post-surgery, 5 weeks post-loading, 8-12 weeks post-loadding, 6 months post-loading, and 12 months post-loading
measure: Buccal bone dimensional changes
timeFrame: Measured at screening and 12 months post-loading
measure: Change in implant stability
timeFrame: Measured at implant placement (immediately at tooth extraction or 16-18 weeks after tooth extraction), implant loading (10-12 weeks after implant surgery), and final restoration (8-12 weeks after implant surgery)
measure: Change in soft tissue - gingival margin
timeFrame: Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
measure: Change in soft tissue - papilla margin
timeFrame: Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
measure: Subject satisfaction with esthetics
timeFrame: Measured at 12 months post-loading
measure: Subject satisfaction with function
timeFrame: Measured at 12 months post-loading
measure: Subject satisfaction with the level of pain
timeFrame: Measured at 12 months post-loading
measure: Frequency of adverse events and adverse device effects
timeFrame: Measured at 12 months post-loading
Other outcomes:
measure: Mean crestal bone level change over long term
timeFrame: Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
measure: Implant success over long term
timeFrame: Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
measure: Implant survival over long term
timeFrame: Measured at 24, 36, 48 and 60 months post-loading
measure: Change in soft tissue - gingival margin over long term
timeFrame: Measured at final restoration (8-12 weeks after loading) and 24, 36, 48 and 60 months post-loading. Note that loading is at 10-12 weeks after surgery.
measure: Change in soft tissue - papilla margin over long term
timeFrame: Measured at final restoration (8-12 weeks after loading) and 24, 36, 48 and 60 months post-loading. Note that loading is at 10-12 weeks after surgery.
measure: Subject satisfaction with esthetics over long term
timeFrame: Measured at 24, 36, 48 and 60 months post-loading
measure: Subject satisfaction with function over long term
timeFrame: Measured at 24, 36, 48 and 60 months post-loading
measure: Subject satisfaction with the level of pain over long term
timeFrame: Measured at 24, 36, 48 and 60 months post-loading
measure: Frequency of adverse events and adverse device effects over long term
timeFrame: Measured at 24, 36, 48 and 60 months post-loading
measure: Buccal bone dimensional changes over long term
timeFrame: Measured at screening and 24, 36, 48 and 60 months post-loading
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Dentistry
state: California
city: Gainesville
country: United States
facility: Center for Implant Dentistry, University of Florida
state: Florida
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: David L. Cochran, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: