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The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.
This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Implants | Experimental | ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) |
|
| Long Implants in combination with bone grafting | Active Comparator | ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) | Device | ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant. | 5 years after permanent restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hämmerle, Prof. Dr. | Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine | Farmington | Connecticut | 06030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25418606 | Result | Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26. | |
| 26425812 |
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The study was amended to include a 10-year follow-up cohort where all subjects enrolled into the initial 5-year study were invited. In total 77 out of the initial 101 subjects consented and were enrolled into the 10-years extension cohort.
| ID | Title | Description |
|---|---|---|
| FG000 | Short Implants | ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) |
| FG001 | Long Implants in Combination With Bone Grafting | ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Study (5 Years) |
|
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| ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting | Device | ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
|
| Time of permanent restoration and 5 years after permanent restoration |
| Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone. | Time of permanent restoration and 10 years after permanent restoration |
| Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level. | 5 years after permanent restoration |
| Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort. | 10 years after permanent restoration |
| Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth. | Time of permanent restoration and 5 years after permanent restoration |
| Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth. | Time of permanent restoration and 10 years after permanent restoration |
| Change in Overall Oral Health Impact Profile (OHIP-49) | OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome. | At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration |
| Change in Overall Oral Health Impact Profile (OHIP-49) | OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome. | At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration |
| Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG | Vienna | A-1090 | Austria |
| Aesthetic Dent | Szczecin | P-71-403 | Poland |
| Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela | Santiago de Compostela | ES-15782 | Spain |
| Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich | Zurich | CH-8032 | Switzerland |
| Result |
| Schincaglia GP, Thoma DS, Haas R, Tutak M, Garcia A, Taylor TD, Hammerle CH. Randomized controlled multicenter study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 2: clinical and radiographic outcomes at 1 year of loading. J Clin Periodontol. 2015 Nov;42(11):1042-51. doi: 10.1111/jcpe.12465. Epub 2015 Nov 27. |
| 28081288 | Result | Pohl V, Thoma DS, Sporniak-Tutak K, Garcia-Garcia A, Taylor TD, Haas R, Hammerle CH. Short dental implants (6 mm) versus long dental implants (11-15 mm) in combination with sinus floor elevation procedures: 3-year results from a multicentre, randomized, controlled clinical trial. J Clin Periodontol. 2017 Apr;44(4):438-445. doi: 10.1111/jcpe.12694. Epub 2017 Mar 6. |
| 30341961 | Result | Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hammerle CHF. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 5-Year data. J Clin Periodontol. 2018 Dec;45(12):1465-1474. doi: 10.1111/jcpe.13025. Epub 2018 Nov 25. |
| 38296249 | Derived | Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Tutak M, Pohl V, Hammerle CHF. Randomized controlled multi-centre study comparing shorter dental implants (6 mm) to longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 10-year data. J Clin Periodontol. 2024 Apr;51(4):499-509. doi: 10.1111/jcpe.13954. Epub 2024 Jan 31. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Extension (10 Years) |
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The baseline analysis population consists of all subjects enrolled into the study, n= 101.
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Implants | ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) |
| BG001 | Long Implants in Combination With Bone Grafting | ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Implant Survival Rate | Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant. | Outcome measure only applicable for the initial study (5 years) cohort. | Posted | Count of Units | Implants | 5 years after permanent restoration | Implants | Implants |
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| Secondary | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone. | Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. 10 subjects within the short implants group had missing or unreadable radiographs and could thus not be included in the analysis. The corresponding number for long implants group was 9 subjects with missing and unreadable radiographs. | Posted | Mean | Standard Deviation | Millimetre | Time of permanent restoration and 5 years after permanent restoration | Implants | Implants |
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| Secondary | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone. | Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. 7 subjects within the short implants group had missing or unreadable radiographs and could thus not be included in the analysis. The corresponding number for long implants group was 9 subjects with missing and unreadable radiographs. | Posted | Mean | Standard Deviation | Millimetre | Time of permanent restoration and 10 years after permanent restoration | implants | implants |
| ||||||||||||||||||||||||||||||
| Secondary | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level. | Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. All subjects were included in the Intention-To-Treat population and were included in the analysis of BoP. | Posted | Count of Participants | Participants | 5 years after permanent restoration |
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| Secondary | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort. | Follow-up Extension (10 years) cohort. At visit 15 (10-years follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects were included in the ITT population and were included in the analysis of BoP. | Posted | Count of Participants | Participants | 10 years after permanent restoration |
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| Secondary | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth. | Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. One subject in the short implants group did not have baseline PPD and was not included in the PPD analysis. | Posted | Mean | Standard Deviation | Millimetre | Time of permanent restoration and 5 years after permanent restoration |
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| Secondary | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth. | Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects were included in the ITT population and were included in the analysis of PPD. | Posted | Mean | Standard Deviation | Millimetre | Time of permanent restoration and 10 years after permanent restoration |
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| Secondary | Change in Overall Oral Health Impact Profile (OHIP-49) | OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome. | Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. All subjects with available OHIP-values from baseline and 5 years after permanent restoration were included in the analysis of overall OHIP-49. | Posted | Mean | Standard Deviation | score on a scale | At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration |
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| Secondary | Change in Overall Oral Health Impact Profile (OHIP-49) | OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome. | Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects with available OHIP-values from baseline and 10 years after permanent restoration were included in the analysis of overall OHIP-49. | Posted | Mean | Standard Deviation | score on scale | At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration |
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From enrollment up to study termination, i.e. up to 5 years post permanent restoration for subjects not consenting to the study prolongation, and up to 10 years post permanent restoration for the 10-years extension cohort.
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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 | Short Implants - All Subjects, Including the 10-years Extension Cohort | ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) | 1 | 50 | 6 | 50 | 23 | 50 |
| EG001 | Long Implants + Grafting - All Subjects, Including the 10-years Extension Cohort | ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with grafing | 0 | 51 | 7 | 51 | 27 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Aorta stent | Cardiac disorders | Non-systematic Assessment |
| ||
| Knee replacement surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Car accident, back injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Chest pain during dental surgery procedure | Cardiac disorders | Non-systematic Assessment |
| ||
| Benign medular tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Blood cancer | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Fracture left shoulder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hematoma upper leg (hospitalization) | Vascular disorders | Non-systematic Assessment |
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| Heart valve replacement | Cardiac disorders | Non-systematic Assessment |
| ||
| Pancreas cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Leg fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abutment related event | Product Issues | Non-systematic Assessment |
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| Swollen after oral surgery | Investigations | Non-systematic Assessment |
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| Crown related event | Product Issues | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Global Clinical Research | Dentsply Sirona Implants | +46313763500 | ClinicalResearchMolndal@dentsplysirona.com |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
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| Adverse Event |
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| Participants |
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| OG001 |
| Long Implants in Combination With Bone Grafting |
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
|
|
| OG001 |
| Long Implants in Combination With Bone Grafting |
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting |
|
|