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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Placement - Test | Other | Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. |
|
| Delayed Placement - Control | Other | Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Bone Level Tapered Implant - Immediate Placement | Device | Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 12 months post-loading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Cochran, DDS, PhD, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Dentistry | Los Angeles | California | 90095-1668 | United States | ||
| Center for Implant Dentistry, University of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Placement - Test | Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. Straumann Bone Level Tapered Implant - Immediate Placement: Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. |
| FG001 | Delayed Placement - Control | Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. Straumann Bone Level Tapered Implant - Delayed Placement: Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Male or female subjects aged 18 years or older required a single tooth extraction in the premolar or anterior region of the maxilla or mandible and met the inclusion criteria but not the exclusion or withdrawal criteria were included in the study population. During the surgical procedure, participants were allowed to have multiple teeth extracted and/or multiple implants inserted, but only one implant was designated as the study implant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Placement - Test | Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. |
| BG001 | Delayed Placement - Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | Change in Mean crestal bone levels (mm) | Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading |
|
For the avoidance of doubt, all AE/SAEs as defined below, regardless of whether they are related to the investigational device, were collected , fully investigated and documented in the source document and appropriate case report form for all subjects from the time of the signing of the informed consent until the 60 months (post-loading) follow-up visit. An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in subjects.
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Placement (= Test Group) | 26 Immediate Placement (= Test Group) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pains | Gastrointestinal disorders | Non-systematic Assessment | Patient experienced chest pains and went to the hospital emergency room where she was kept overnight to fully evaluate findings. It was determined that she was not having a heart attack but rather gastric reflux |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blisters on my back | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Patient developed painful area on right shoulder. Physician described lesion as ""shingles"" (Herpes Zoster) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelica Luque Gonzalez | Institut Straumann | 0034680383996 | angelica.luque@straumann.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2018 | Sep 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2019 | Sep 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Straumann Bone Level Tapered Implant - Delayed Placement | Device | Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. |
|
| 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. | 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. | 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 at Implant Loading | 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 Loading=implant surgery + 10 weeks (+/-3 weeks) |
| Implant Stability as Measured by ISQ at Final Restoration | 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. | Final Restoration: 10 weeks post-loading (± 2 weeks) |
| Change in Soft Tissue Measurements | 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) | 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)). |
| Subject Satisfaction | 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. | 12 months post-loading |
| Number of Participants With Adverse Events and Adverse Device Effects Over 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. | Measured at each study visit and throughout 12 months |
| Gainesville |
| Florida |
| 32610-0434 |
| United States |
| University of Texas Health Science Center San Antonio | San Antonio | Texas | 78229 | United States |
Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Delayed Placement (Control Group) | Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. |
|
|
|
| Secondary | 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.
| 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) | Posted | Count of Participants | Participants | 12 months post-loading |
|
|
|
| Secondary | 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. | At Implant Loading - Test group N=23, Control N=23 At 12 month Follow Up - Test group N=22, Control N=23 | Posted | Mean | Standard Deviation | mm | Measured at Implant loading and at screening and 12 months post-loading |
|
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Implant Stability as Measured by ISQ at Implant Loading | 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. | 23 subjects from Test group and 24 from Control group had ISQ assessed at Implant Loading. | Posted | Count of Participants | Participants | Implant Loading=implant surgery + 10 weeks (+/-3 weeks) |
|
|
|
| Secondary | Implant Stability as Measured by ISQ at Final Restoration | 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. | 23 subjects from Test and 24 from Control group had ISQ assessed at Final Restoration visit. | Posted | Count of Participants | Participants | Final Restoration: 10 weeks post-loading (± 2 weeks) |
|
|
|
| Secondary | Change in Soft Tissue Measurements | 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) | 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). | Posted | Mean | Standard Deviation | mm | 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)). |
|
|
|
| Secondary | Subject Satisfaction | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 12 months post-loading |
|
|
|
| Secondary | Number of Participants With Adverse Events and Adverse Device Effects Over 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. | 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. | Posted | Count of Participants | Participants | Measured at each study visit and throughout 12 months |
|
|
|
| 26 |
| 2 |
| 26 |
| 8 |
| 26 |
| EG001 | Delayed Placement (= Control Group) | 27 Delayed Placement (= Control Group) | 0 | 27 | 4 | 27 | 11 | 27 |
|
| Right knee replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject called the day before the surgery to inform us she was having knee replaced the next day. |
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| Bacterial Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Bacterial Pneumonia |
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| Colon Cancer | Gastrointestinal disorders | Non-systematic Assessment | Subject was diagnosed with colon cancer |
|
| Hernia surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Surgery to repair hernia |
|
| Aortic valve replacement | Cardiac disorders | Non-systematic Assessment | Patient called on 30-Mar-2018 to inform site he was having aortic valve replacement on 4-APR-2018. |
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| E. Coli | Infections and infestations | Non-systematic Assessment | Patient reported he was hospitalized with E. coli from June 23-28 with IV antibiotics. |
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| Knee replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | prosthesis knee replacement |
|
|
| Patient stated pain started one week after bridge was placed at #4-#6 on 16NOV2018. Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Bridge removed, surgical intervention on site #5, Bony defect noted at #6d possibly due to resorption at extraction site#5.Debrided and irrigated, sutures placed |
|
| Bony defect | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Bridge removed, surgical intervention on site #5, Bony defect noted at #6d possibly due to resorption at extraction site#5.Debrided and irrigated, sutures placed |
|
| anaphylactic reaction | Immune system disorders | Non-systematic Assessment | After 5 days of amoxicillin, 500mg, patient went to restaurant for seafood. He experienced shortly thereafter lip and faced were swollen and he had difficulty breathing. He went to emergency department (unknown location) |
|
| Subject had discomfort around surgical area. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Intra oral exam shows some irritation around suture on #8 site. |
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| Mass found in ovaries | Reproductive system and breast disorders | Non-systematic Assessment | patient report mass found in ovaries and it was biopsied. patient did not know results at time of study |
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| Tooth #4 Fractured | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | radiograph taken. Subject give choice of extraction and implant versus RCT and Crown. Subject elected and was scheduled for RCT and Crown |
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| Numbness in face | Nervous system disorders | Non-systematic Assessment | Patient reported after getting flu shot she got numbness in face, xerostomia, and double vision. |
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| Xerostomia | Nervous system disorders | Non-systematic Assessment | Patient reported getting Xerostomia after receiving flu shot |
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| Double Vision | Eye disorders | Non-systematic Assessment | patient had double vision after receiving flu shot |
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| Parathyroid tumor removed | Endocrine disorders | Non-systematic Assessment | parathyroid tumor removed due to double vision and numbness in face |
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| Nerve Graft Repair | Nervous system disorders | Non-systematic Assessment | Subject was cutting pineapple and sliced her right thumb. Subject had outpatient nerve repair. |
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| Implant Mobility | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Implant mobile - poor occlusion. Failing dentition with no posterior support. |
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| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | Experience vertigo after hernia surgery. |
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| Fracture in right foot and toe | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fell and fractured right foot and toe. |
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| Compression Fracture L-1 | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Compression fracture to L-1 due to a fall |
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| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | Small bowel obstruction resolved on its own. |
|
| Salivary stone (mandible) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject reports salivary stone, mandibular arch, treated with antibiotics and sour candy. |
|
| Right shoulder surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Tendonitis in right shoulder and bicep. Surgery on right shoulder repair tendon. |
|
| Small fracture in crown on study tooth | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Small incisal edge porcelain chip on crown of study tooth. |
|
| radiolucency around the implant | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Radiolucency around implant at the time of provisional crown delivery. Will follow-up in a week to reevaluate. |
|
| implant removed | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Provisional crown was removed and ISQ was 34-35. Implant was mobile and removed. No acute infection was seen (no purulence, edema, or erythema). Granulation tissue was curetted from around the crest of the alveolar ridge and grafted with allograft. |
|
| rash on upper chest area possible reaction on antibiotic or mosquito bites | Immune system disorders | Non-systematic Assessment | on the phone subject complained on redness on the body at the visit: rash visible on upper chest area |
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| infection at implant site with suppuration. Patient came for follow up | Infections and infestations | Non-systematic Assessment | edema, minimal pus, tenderness on buccal and crestal gingiva but no implant dehiscence inflammation around implant (improved from last visit), edema, erythema buccal and crestal site #9 |
|
| inflammation around implant (improved from last visit) | Immune system disorders | Non-systematic Assessment | edema and erythema buccal and crestal site # 9, no purulence |
|
| implant came out. Fu S/P removal of failed #9 implant | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | inflammation, edema, erythema, implant is out ST closure achieved. No signs of infection. B-l deficiency present at implant site, will require GBR prior to implant replacement Recommended 4 weeks healing prior to GBR |
|
| diagnosis breast cancer | Reproductive system and breast disorders | Non-systematic Assessment | Not able to complete study procedures due to treatment |
|
| Loss of crown | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Loss of cement retention of prosthesis |
|
| final screw retained crown delivery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | temporary screw retained crown removed and final screw retained crown delivered |
|
| Cold sore | Skin and subcutaneous tissue disorders | Systematic Assessment | Subject reported cold sore on upper lip. |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Patient had urinary tract infection |
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| Esophageal Tear | Injury, poisoning and procedural complications | Systematic Assessment | Patient was hospitalized for an esophageal tear. He was treated and released. |
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| Worsening high blood pressure | Blood and lymphatic system disorders | Systematic Assessment | Subject reported an increase in high blood pressure over a period of 9 weeks. |
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| Loose crown | Injury, poisoning and procedural complications | Systematic Assessment | Subject felt crown loose, but did not fall off. Appointed for the next day, cemented crown removed, and screw retained temporary replaced. New screw retained final crown will be made. |
|
| facial implant/fistula | Infections and infestations | Systematic Assessment | patient presented with soft tissue fistula from food impaction. The fistula is not related to the study device |
|
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Not provided
| ISQ ≥ 70 |
|
| ISQ Value 2: Probe held mesial-lingual |
|
| ISQ ≥ 70 |
|
| ISQ Value 2: Probe held mesial-lingual measured at Implant Loading |
|
| ISQ ≥ 70 |
|
| ISQ Value 2: Probe held mesial-lingual |
|
| Change in CLI from final restoration to 12-month follow-up (mm) |
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| Change in IPm from final restoration to 12-month follow-up (mm) |
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| Change in IPd from final restoration to 12-month follow-up (mm) |
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| Satisfaction with esthetics |
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| Device Related |
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| Procedure Related |
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| Serious Adverse Events |
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| Serious Adverse Device Events |
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| SAE Device Related |
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| SAE Procedure Related |
|