Jaw, Edentulous, Partially
Conditions
Brief summary
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.
Detailed description
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.
Interventions
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Sponsors
Study design
Eligibility
Inclusion criteria
* Provision of informed consent * Aged 20-75 years at enrolment * History of edentulism in the study area of at least four months * In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region) * Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator * Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s * Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 6 mm * Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria
* Unlikely to be able to comply with study procedures, as judged by the investigator * Earlier bone graft procedures in the study area * Uncontrolled pathologic processes in the oral cavity * Known or suspected current malignancy * History of radiation therapy in the head and neck region * History of chemotherapy within 5 years prior to surgery * Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration * Uncontrolled diabetes mellitus * Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration * Smoking more than 10 cigarettes/day * Bruxism * Present alcohol and/or drug abuse * Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) * Previous enrolment in the present study * Simultaneous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 5 years after permanent restoration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | Time of permanent restoration and 5 years after permanent restoration | 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. |
| Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | 5 years after permanent restoration | 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. |
| Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | Time of permanent restoration and 5 years after 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. |
| Change in Overall Oral Health Impact Profile (OHIP-49) | At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration | 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. |
Countries
Austria, Poland, Spain, Switzerland, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Short Implants ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm) | 50 |
| Long Implants in Combination With Bone Grafting ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Extension (10 Years) | Adverse Event | 1 | 2 |
| Follow-up Extension (10 Years) | Lost to Follow-up | 5 | 4 |
| Follow-up Extension (10 Years) | Withdrawal by Subject | 1 | 3 |
| Initial Study (5 Years) | Death | 1 | 0 |
| Initial Study (5 Years) | Implant failure | 1 | 0 |
| Initial Study (5 Years) | Lost to Follow-up | 4 | 5 |
Baseline characteristics
| Characteristic | Short Implants | Long Implants in Combination With Bone Grafting | Total |
|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 12.88 | 50.5 years STANDARD_DEVIATION 14.05 | 50.4 years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 29 Participants | 23 Participants | 52 Participants |
| Sex: Female, Male Male | 21 Participants | 28 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 51 |
| other Total, other adverse events | 23 / 50 | 27 / 51 |
| serious Total, serious adverse events | 6 / 50 | 7 / 51 |
Outcome results
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.
Time frame: 5 years after permanent restoration
Population: Outcome measure only applicable for the initial study (5 years) cohort.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Short Implants | Implant Survival Rate | 66 Implants |
| Long Implants in Combination With Bone Grafting | Implant Survival Rate | 70 Implants |
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.
Time frame: Time of permanent restoration and 5 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | -0.12 Millimetre | Standard Deviation 0.535 |
| Long Implants in Combination With Bone Grafting | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | -0.18 Millimetre | Standard Deviation 0.959 |
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 frame: Time of permanent restoration and 10 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | -0.12 Millimetre | Standard Deviation 0.68 |
| Long Implants in Combination With Bone Grafting | Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level | -0.24 Millimetre | Standard Deviation 0.82 |
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.
Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Change in Overall Oral Health Impact Profile (OHIP-49) | -2.2 score on scale | Standard Deviation 19.1 |
| Long Implants in Combination With Bone Grafting | Change in Overall Oral Health Impact Profile (OHIP-49) | -9.8 score on scale | Standard Deviation 16.3 |
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.
Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Change in Overall Oral Health Impact Profile (OHIP-49) | -12 score on a scale | Standard Deviation 26.3 |
| Long Implants in Combination With Bone Grafting | Change in Overall Oral Health Impact Profile (OHIP-49) | -16.9 score on a scale | Standard Deviation 23.9 |
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 frame: Time of permanent restoration and 5 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | -0.26 Millimetre | Standard Deviation 0.91 |
| Long Implants in Combination With Bone Grafting | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | -0.43 Millimetre | Standard Deviation 1.02 |
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 frame: Time of permanent restoration and 10 years after permanent restoration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Implants | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | -0.4 Millimetre | Standard Deviation 1.2 |
| Long Implants in Combination With Bone Grafting | Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | -0.7 Millimetre | Standard Deviation 1.5 |
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.
Time frame: 5 years after permanent restoration
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Implants | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | 18 Participants |
| Long Implants in Combination With Bone Grafting | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | 23 Participants |
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.
Time frame: 10 years after permanent restoration
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Implants | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | 16 Participants |
| Long Implants in Combination With Bone Grafting | Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP) | 23 Participants |