Bone Level Tapered Multi-Center Study

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

Population: 65 subjects were screened, 11 were screen failures and 1 pre-randomizatio lost to follow-up.~From the 53 subjects randomized (ITT group), 50 subjects (25 in the test, 25 in the control group) received the study treatment (mITT).~Among mITT group, 5 lacked primary analysis measurements: 3 control, 2 test.~Test group (N=23) had 1 lost follow-up, 1 lost implant post-op. Control group (N=22) had 1 baseline measurement missing, 2 lost implants post-restoration.

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

Population: At Implant Loading - Test group N=23, Control N=23 At 12 month Follow Up - Test group N=22, Control N=23

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)

Time frame: 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)).

Population: Measurements of soft tissue changes around the implant were recorded at both the time of final restoration (10 weeks post-loading) and the 12-month Follow-up (12 months post-loading). Specifically, 23 subjects from the Test group and 23 from the Control group had their soft tissue measurements changes assessed at 12 months follow-up (post-loading).

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

Population: Implant stability was measured by resonance frequency analysis implant surgery. 25 subject from each group (control and test) received an implant and had ISQ assessed.

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.

Time frame: Final Restoration: 10 weeks post-loading (± 2 weeks)

Population: 23 subjects from Test and 24 from Control group had ISQ assessed at Final Restoration visit.

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.

Time frame: Implant Loading=implant surgery + 10 weeks (+/-3 weeks)

Population: 23 subjects from Test group and 24 from Control group had ISQ assessed at Implant 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

Time frame: 12 months post-loading

Population: 65 subjects were screened, 11 were screen failures and 1 pre-randomizatio lost to follow-up.~From the 53 subjects randomized (ITT group), 50 subjects received the study treatment (mITT).~Test group (N=24) had 1 lost follow-up Control group (N=25)

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.

Time frame: Measured at each study visit and throughout 12 months

Population: Over a 12-month period, 38 adverse events (AEs) were reported among 18 of the 53 study subjects. The randomization process assigned 26 subjects to the test group (=immediate placement) and 27 subjects to the control group (=delayed placement). No serious adverse events (SAEs) related to the procedure or device were observed.

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.

Time frame: 12 months post-loading

Population: In each group, Test and Control, 25 subjects underwent implant placement, and Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed using Visual Analog Scales (VAS).~Specifically, 23 subjects from the Test group and 23 from the Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS).