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This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed EV implant | Device | The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Survived Implants at Time of the Follow-up Visit | Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level. | Up to 66 months post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Successful Implants at Time of the Follow-up Visit | Implant success defined as implant in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the implant or adjacent peri-implant tissues reported from the day when the study product(s) was installed until the end of the study. Analysis performed on implant level. | Up to 66 months post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of individuals who received OsseoSpeed EV implants, during January 1st 2015 to December 31st 2016, as part of a prosthetic restoration replacing one or more teeth, in any position in the mouth.
The results from this study should be representative for the general population, therefore there will be no subject related restrictions regarding which subjects to include in the study population (except that the subjects needs to be at least 18 years old at time of implant installation).
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| Name | Affiliation | Role |
|---|---|---|
| Stijn Vervaeke, MD | Centrum voor tandheelkunde Geluwe, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois College of Dentistry | Chicago | Illinois | 660612 | United States | ||
| Centrum voor tandheelkunde Geluwe |
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The subject population recruited in this retrospective study consisted of individuals who received OsseoSpeed EV implants between January 1st 2015 and December 31st 2016, as part of a prosthetic restoration replacing one or more teeth in any position of the mouth.
| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed EV Implant | The investigational product (OsseoSpeed EV implant) was already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2018 |
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| Percent of Successful Prosthetics at Time of the Follow-up Visit | Prosthetic success defined as implant, abutment and restoration in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the reconstruction or adjacent peri-implant tissues reported from the day when the study position(s) was permanently included in a prosthetic restoration until the end of the study. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Marginal Bone Levels (MBL) | Bone tissue response was evaluated for each investigational position by measuring Marginal Bone Levels (MBL) on the radiographs. Intraoral radiographs were used. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit | Soft tissue response evaluated by measuring the PPD of each study position. PPD was evaluated using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probable pocket in whole millimeters. PPD mean values, and frequencies per depth, were calculated for each study position. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit | Presence of BoP was evaluated using a periodontal probe. The proportion of surfaces that showed presence of bleeding were calculated and presented for each study implant position. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit | Plaque was recorded as presence or absence of plaque by visual inspection. The proportion of surfaces that showed presence of plaque were calculated and presented for each study implant position. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Patient Reported Outcome on Implant Level at Time of Follow-up Visit | Subject satisfaction was evaluated using a short subject questionnaire of each investigational implant position. Subjects were asked to complete a questionnaire to state their opinion about: 1) chewing function and 2) esthetics and 3) overall level of treatment satisfaction. For question 1) the scale ranged from Very bad (1), Bad (2), Neither bad or good (3), Good (4), and Very good (5). For questions 2) and 3) the scale ranged from Very dissatisfied (1), Dissatisfied (2), Neither dissatisfied nor satisfied (3), Satisfied (4), and Very satisfied (5). Authorized investigational site personnel provided the questionnaire during the investigational visit. The subject was instructed to complete it, one per investigational position, and return it for data entry by site personnel into the electronic-Case Report Form (eCRF). The frequencies of each score were calculated for each question and investigational position. Analysis performed on implant level. | Up to 66 months post-procedure. |
| Geluwe |
| 8940 |
| Belgium |
| Burlington Prosthodontics | Burlington | ON L7S 1T8 | Canada |
| Oral Hammaslääkärit | Helsinki | 00250 | Finland |
| Implantarium Gernsbach | Gernsbach | 765 93 | Germany |
| Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie | Heidelberg | 69120 | Germany |
| Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery | Halmstad | 301 85 | Sweden |
|
| COMPLETED | Initiated (completed Visit 1). Included in the PP analysis. |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed EV Implant | The investigational product (OsseoSpeed EV implant) was already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Smoking status | Count of Participants | Participants |
| ||||||||||||||||||
| Number of implants per subject | Number | Implants |
|
| 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 | Percent of Survived Implants at Time of the Follow-up Visit | Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level. | PP-analysis set | Posted | Count of Units | Implants | Up to 66 months post-procedure. | Implants | Implants |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Successful Implants at Time of the Follow-up Visit | Implant success defined as implant in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the implant or adjacent peri-implant tissues reported from the day when the study product(s) was installed until the end of the study. Analysis performed on implant level. | PP-analysis set | Posted | Count of Units | Implants | Up to 66 months post-procedure. | Implants | Implants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percent of Successful Prosthetics at Time of the Follow-up Visit | Prosthetic success defined as implant, abutment and restoration in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the reconstruction or adjacent peri-implant tissues reported from the day when the study position(s) was permanently included in a prosthetic restoration until the end of the study. Analysis performed on implant level. | PP-analysis set | Posted | Number | Prosthetic outcome | Up to 66 months post-procedure. | Implants | Implants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Marginal Bone Levels (MBL) | Bone tissue response was evaluated for each investigational position by measuring Marginal Bone Levels (MBL) on the radiographs. Intraoral radiographs were used. Analysis performed on implant level. | PP-analysis set used for analysis of MBL values at follow-up visit. All subjects with available baseline radiographs were included in the baseline MBL analysis. | Posted | Mean | Standard Deviation | mm | Up to 66 months post-procedure. | Implants | Implants |
|
| ||||||||||||||||||||||||||||||
| Secondary | Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit | Soft tissue response evaluated by measuring the PPD of each study position. PPD was evaluated using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probable pocket in whole millimeters. PPD mean values, and frequencies per depth, were calculated for each study position. Analysis performed on implant level. | PP-analysis set | Posted | Mean | Standard Deviation | mm | Up to 66 months post-procedure. | Implants | Implants |
|
| ||||||||||||||||||||||||||||||
| Secondary | Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit | Presence of BoP was evaluated using a periodontal probe. The proportion of surfaces that showed presence of bleeding were calculated and presented for each study implant position. Analysis performed on implant level. | PP-analysis set | Posted | Number | Number of implants with bleeding | Up to 66 months post-procedure. | Implants | Implants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit | Plaque was recorded as presence or absence of plaque by visual inspection. The proportion of surfaces that showed presence of plaque were calculated and presented for each study implant position. Analysis performed on implant level. | PP-analysis set | Posted | Number | Number of implants with plaque | Up to 66 months post-procedure. | Implants | Implants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Patient Reported Outcome on Implant Level at Time of Follow-up Visit | Subject satisfaction was evaluated using a short subject questionnaire of each investigational implant position. Subjects were asked to complete a questionnaire to state their opinion about: 1) chewing function and 2) esthetics and 3) overall level of treatment satisfaction. For question 1) the scale ranged from Very bad (1), Bad (2), Neither bad or good (3), Good (4), and Very good (5). For questions 2) and 3) the scale ranged from Very dissatisfied (1), Dissatisfied (2), Neither dissatisfied nor satisfied (3), Satisfied (4), and Very satisfied (5). Authorized investigational site personnel provided the questionnaire during the investigational visit. The subject was instructed to complete it, one per investigational position, and return it for data entry by site personnel into the electronic-Case Report Form (eCRF). The frequencies of each score were calculated for each question and investigational position. Analysis performed on implant level. | PP-analysis set | Posted | Mean | Standard Deviation | score on a scale | Up to 66 months post-procedure. | Completed questionnaires | Completed questionnaires |
|
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Minimum of 2 years of use up to a maximum of around 4½ years of use
The safety objective of this retrospective investigation was to collect all Adverse Device Effects (ADEs) and Serious Adverse Effects (SADEs), i.e., events related to implants, abutment, restoration, or adjacent peri-implant tissues reported from the day when the implant(s) was installed until the end of the investigation (Visit 1). Due to the retrospective design, non-related Adverse Events (AEs) and Serious Adverse Effects (SAEs) have not been collected.
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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 | OsseoSpeed EV Implant | The investigational product (OsseoSpeed EV implant) was already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products. | 0 | 208 | 0 | 208 | 15 | 208 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abutment related | Product Issues | Non-systematic Assessment | Mechanical/technical events related to abutment. |
| |
| Prosthesis related | Product Issues | Non-systematic Assessment | Mechanical/technical events related to prosthesis. |
| |
| Peri-implant tissue related | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Center of Clinical Research, AnnaKarin Lundgren | Dentsply IH AB d.b.a Dentsply Sirona Implants | +46 31 376 30 00 | annakarin.lundgren@dentsplysirona.com |
| Sep 19, 2022 |
| Prot_SAP_000.pdf |
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| Belgium |
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| United States |
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| Finland |
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| Germany |
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| Occasional smoker |
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| Habitual smoker |
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| 3 implants |
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| 4 implants |
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| 5 implants |
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| 6 implants |
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| 7 implants |
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| 8 implants |
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| Implants |
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| Implants |
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| Participants |
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| Implants |
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| Implants |
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| Implants |
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| Implants |
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| Participants |
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| Completed questionnaires |
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