Bone Level Tapered Multi-Center Study

Not Applicable

Active, not recruiting

Conditions: Tooth Loss

Registration Number: NCT02569671

Lead Sponsor: Institut Straumann AG

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 53

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Crestal Bone Level Change	Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading	mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level

Secondary Outcome Measures

Name	Time	Method
Implant Success and Survival	12 months post-loading	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
Buccal Bone Dimensional Changes	Measured at Implant loading and at screening and 12 months post-loading	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.
Implant Measure as Measured by ISQ at Implant Surgery	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	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.
Implant Stability as Measured by ISQ at Implant Loading	Implant Loading=implant surgery + 10 weeks (+/-3 weeks)	Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual. An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is 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 will be taken from two different angles at implant placement, implant loading, and final restoration.
Implant Stability as Measured by ISQ at Final Restoration	Final Restoration: 10 weeks post-loading (± 2 weeks)	Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual. An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is 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 will be taken from two different angles at implant placement, implant loading, and final restoration.
Change in Soft Tissue Measurements	Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).	The following table illustrates a comparison between Soft Tissue Mean Changes Around the Implant for delayed and immediate placements, measured at final restoration (10 weeks post loading) and the 12-month mark post implant loading. The parameters assessed included: CLTm (length of crown from highest point of soft tissue to incisal edge of the adjacent mesial tooth), CLTd (length of crown from highest point of soft tissue to incisal edge of the adjacent distal tooth), 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)
Subject Satisfaction	12 months post-loading	Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS). Satisfaction range between 0 to 100 with Excruciating and Not satisfied at all at zero point and Nonexistent and Extremely satisfied at the 100 point. The table summarizes pain, satisfaction with function and satisfaction with esthetics at 12-months post loading.
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months	Measured at each study visit and throughout 12 months	The frequency of adverse events and adverse device effects will be determined at 12 months post-loading and compared between the test and control arms. There were 38 total Adverse Events in 18 subjects out of 53 subjects. There were no SAEs related to procedure or device.

Trial Locations

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
UCLA School of Dentistry
🇺🇸Los Angeles, California, United States