Bone Level Tapered Multi-Center Study

N/AActive Not RecruitingNCT02569671

Institut Straumann AG53 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tooth Loss

Interventions

Straumann Bone Level Tapered Implant - Immediate PlacementDEVICE

Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Straumann Bone Level Tapered Implant - Delayed PlacementDEVICE

Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

UCLA School of Dentistry

Los Angeles, California, United States

Center for Implant Dentistry, University of Florida

Gainesville, Florida, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Mean Crestal Bone Level Change

mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level

Time frame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading

Secondary Outcomes

Implant Success and Survival

Control group N-25 Test group N=24 Survival and success was assessed by the dimensions below as noted by Buser. * 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

Time frame: 12 months post-loading

Buccal Bone Dimensional Changes

Buccal bone dimensional changes were measured on images recorded on cone beam computed tomography (CBCT). The average of the following measurement locations is reported as outcome variable: 1\) mesial to distal; 2) distal-buccal; 3) mid-buccal; 4) mesial-buccal; 5) distal-lingual; 6) mid-lingual; 7) mesial-lingual.

Time frame: Measured at Implant loading and at screening and 12 months post-loading

Implant Measure as Measured by ISQ at Implant Surgery

Implant stability as measured by ISQ held facial-lingual and held mesial-lingual. An Osstell device that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration was used in the study. The results were presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements were taken from two different angles at implant placement, implant loading, and final restoration.

Time frame: Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing

Data from ClinicalTrials.gov

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