Jaw, Edentulous, Partially
Conditions
Brief summary
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.
Interventions
DEVICEOsseoSpeed™ length 6 mm
OsseoSpeed™ dental implant, length: 6 mm
DEVICEOsseoSpeed™ length 11 mm
OsseoSpeed™ dental implant, length: 11 mm
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Aged 20-70 years at enrolment * History of edentulism in the study area of at least four months * Neighboring tooth/teeth to the planned bridge must have natural root(s) * Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge. * Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 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 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 or any other medication that could influence post-operative healing and/or osseointegration * Smoking more than 10 cigarettes/day * 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. * Severe non-compliance to protocol as judged by the investigator and/or Astra Tech * Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Assessments of Marginal Bone Level Alteration | Evaluated from implant installation to 5 years follow-up after implant placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Implant Survival | Evaluated 5 years after implant placement | Overall implant survival, measured on implant level |
| Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | Measured at the 5-year follow-up visit after loading | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | Evaluated at implant loading and at the 5-year follow-up visit. | 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. |
| Presence of Plaque | Evaluated at the 5-year follow-up visit after loading. | 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. |
Countries
Australia, Netherlands, Sweden, United Kingdom, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group-1, Implant Length 6 mm Subjects treated with OsseoSpeed™ implant, length: 6 mm | 49 |
| Group-2, Implant Length 11 mm Subjects treated with OsseoSpeed™ implant, length: 11 mm | 46 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Group-1, Implant Length 6 mm | Group-2, Implant Length 11 mm | Total |
|---|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 9.39 | 54.1 years STANDARD_DEVIATION 10.04 | 54.5 years STANDARD_DEVIATION 9.67 |
| Region of Enrollment Australia | 4 participants | 6 participants | 10 participants |
| Region of Enrollment Netherlands | 17 participants | 16 participants | 33 participants |
| Region of Enrollment Sweden | 3 participants | 2 participants | 5 participants |
| Region of Enrollment United Kingdom | 7 participants | 8 participants | 15 participants |
| Region of Enrollment United States | 18 participants | 14 participants | 32 participants |
| Sex: Female, Male Female | 28 Participants | 19 Participants | 47 Participants |
| Sex: Female, Male Male | 21 Participants | 27 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 49 | 12 / 46 |
| serious Total, serious adverse events | 8 / 49 | 5 / 46 |
Outcome results
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.
Time frame: Evaluated from implant installation to 5 years follow-up after implant placement
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-1, Implant Length 6 mm | Radiological Assessments of Marginal Bone Level Alteration | 0.02 millimeter | Standard Deviation 0.52 |
| Group-2, Implant Length 11 mm | Radiological Assessments of Marginal Bone Level Alteration | -0.18 millimeter | Standard Deviation 1.05 |
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.
Time frame: Measured at the 5-year follow-up visit after loading
Population: A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of BoP.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Group-1, Implant Length 6 mm | Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | 43 implants |
| Group-2, Implant Length 11 mm | Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | 28 implants |
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.
Time frame: Evaluated at implant loading and at the 5-year follow-up visit.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-1, Implant Length 6 mm | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | -0.57 millimeters | Standard Deviation 0.92 |
| Group-2, Implant Length 11 mm | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | -1.11 millimeters | Standard Deviation 1.77 |
Secondary
Overall Implant Survival
Overall implant survival, measured on implant level
Time frame: Evaluated 5 years after implant placement
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Group-1, Implant Length 6 mm | Overall Implant Survival | 101 implants |
| Group-2, Implant Length 11 mm | Overall Implant Survival | 100 implants |
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.
Time frame: Evaluated at the 5-year follow-up visit after loading.
Population: A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of presence of plaque.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Group-1, Implant Length 6 mm | Presence of Plaque | 16 implants |
| Group-2, Implant Length 11 mm | Presence of Plaque | 6 implants |