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The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-1, Implant length 6 mm | Experimental | Subjects treated with OsseoSpeed™ implant, length: 6 mm |
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| Group-2, Implant length 11 mm | Other | Subjects treated with OsseoSpeed™ implant, length: 11 mm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ length 6 mm | Device | OsseoSpeed™ dental implant, length: 6 mm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Assessments of Marginal Bone Level Alteration | Marginal Bone Level determined from radiographs and expressed as the difference 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 millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. | Evaluated from implant installation to 5 years follow-up after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Implant Survival | Overall implant survival, measured on implant level | Evaluated 5 years after implant placement |
| Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna-Karin Lundgren | Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC School of Dentistry | Los Angeles | California | 90089-0641 | United States | ||
| The University of Iowa, College of Dentistry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22938573 | Result | Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3. | |
| 30003598 | Result | Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12. |
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97 subjects were enrolled in the study (singed informed consent).Two of those subjects fulfilled exclusion criteria and were removed from the study population before randomization.
As a consequence a total of 95 subjects were randomised (assigned to groups) and received study treatment.
| ID | Title | Description |
|---|---|---|
| FG000 | Group-1, Implant Length 6 mm | Subjects treated with OsseoSpeed™ implant, length: 6 mm |
| FG001 | Group-2, Implant Length 11 mm | Subjects treated with OsseoSpeed™ implant, length: 11 mm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OsseoSpeed™ length 11 mm |
| Device |
OsseoSpeed™ dental implant, length: 11 mm |
|
| Measured at the 5-year follow-up visit after loading |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. | Evaluated at implant loading and at the 5-year follow-up visit. |
| Presence of Plaque | Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. | Evaluated at the 5-year follow-up visit after loading. |
| Iowa City |
| Iowa |
| 52242-1010 |
| United States |
| School of Dental Science, University of Melbourne | Melbourne | Victoria | 3010 | Australia |
| Praktijk De Mondhoek | Apeldoorn | 7315 | Netherlands |
| Dept. of Parodontology, Göteborg University | Gothenburg | SE 405 30 | Sweden |
| King's College London Dental Institute at Guy's King's and St Thomas' Hospitals | London | SE1 9RT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group-1, Implant Length 6 mm | Subjects treated with OsseoSpeed™ implant, length: 6 mm |
| BG001 | Group-2, Implant Length 11 mm | Subjects treated with OsseoSpeed™ implant, length: 11 mm |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Radiological Assessments of Marginal Bone Level Alteration | Marginal Bone Level determined from radiographs and expressed as the difference 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 millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. | A total of 85 subjects (184 implants) completed the study. For a total of 10 implants (in 5 subjects) the quality of the radiographs were not sufficient for reading, giving a total of 80 subjects (174 implants) for the analysis of MBL change. | Posted | Mean | Standard Deviation | millimeter | Evaluated from implant installation to 5 years follow-up after implant placement | Implants | Implants |
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| Secondary | Overall Implant Survival | Overall implant survival, measured on implant level | Group-1. A total of 49 subjects (108 positions) underwent surgery. Three positions were not implanted due to complications during surgery. Giving a total 105 implants installed. Group-2. A total of 46 subjects (101 positions) underwent surgery. Giving a total of 101 implants installed. | Posted | Count of Units | implants | Evaluated 5 years after implant placement | implants | implants |
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| Secondary | Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP. | A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of BoP. | Posted | Count of Units | implants | Measured at the 5-year follow-up visit after loading | implants | implants |
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| Secondary | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. | A total of 85 subjects (184 implants) completed the 5-year follow-up visit. Group-1. For 3 subjects (7 implants) the radiographs were not possible to evaluate, giving a total of 43 subjects (91 implants) being available for evaluation of change in PPD. Group-2. All radiographs readable, giving 39 subjects (86 positions) for the evaluation. | Posted | Mean | Standard Deviation | millimeters | Evaluated at implant loading and at the 5-year follow-up visit. | implants | implants |
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| Secondary | Presence of Plaque | Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. | A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of presence of plaque. | Posted | Count of Units | implants | Evaluated at the 5-year follow-up visit after loading. | implants | implants |
|
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5 years
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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 | Group-1, Implant Length 6 mm | Subjects treated with OsseoSpeed™ implant, length: 6 mm | 8 | 49 | 13 | 49 | ||
| EG001 | Group-2, Implant Length 11 mm | Subjects treated with OsseoSpeed™ implant, length: 11 mm | 5 | 46 | 12 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Osteopaenia, trauma - fractured toes | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Insufficient renal function (30%) | Renal and urinary disorders | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | Systematic Assessment |
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| Undefined heart problems | Cardiac disorders | Systematic Assessment |
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| Failure knee-prosthesis | Product Issues | Systematic Assessment |
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| Hip function failure | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gallbladder removed | Hepatobiliary disorders | Systematic Assessment |
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| Right hip replacement, post-op infection | Infections and infestations | Systematic Assessment |
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| Armpit abscess due to spider bite. | Infections and infestations | Systematic Assessment |
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| Bilateral toe infection | Infections and infestations | Systematic Assessment |
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| Liver cancer | Hepatobiliary disorders | Non-systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Broken pelvis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pneumonitis - Non Hodgkin disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hip fracture due to car accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ovarian cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Eye cancer (basal cell carcinoma) | Eye disorders | Systematic Assessment |
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| Squamous cell skin cancer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study implant failure | Product Issues | Non-systematic Assessment | Study implant failure (including implant mobility, excessive bone loss around implant and, implant related pain) |
| |
| Bridge screw loosening | Product Issues | Non-systematic Assessment | Loosening of the screw attaching the restoration (the bridge) to the implant abutment. |
| |
| Abutment fracture | Product Issues | Non-systematic Assessment | Fracture of the abutment connecting the implant with the restoration |
| |
| Fracture of temporary bridge | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | 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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| Netherlands |
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