Edentulism
Conditions
Brief summary
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction. The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
Interventions
ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Aged 18-75 years at enrolment * A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site * History of edentulism in the study area of at least 3 months * Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement. * In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position) * Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria
* Uncontrolled pathological 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 would compromise post-operative healing and/or osseointegration * Uncontrolled diabetes mellitus * Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Smoking more than 10 cigarettes per day * Present alcohol and/or drug abuse * Current need for bone grafting in the planned implant area * Previous enrolment in the present study * Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months * Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site) * Unlikely to be able to comply with study procedures, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement | At baseline and 16 weeks | Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 21 weeks, 12 months, 24 months and 36 months post implant placement. | The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal. |
| Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement | MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis. |
| Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | 21 weeks, 12 months, 24 months, and 36 months post implant placement | BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site. |
| Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | Baseline and 12 months, 24 months, and 36 months post implant placement | PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level. |
| Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | Baseline and 12 months, 24 months, and 36 months post implant placement | CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level. |
Countries
Germany, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Treated With ASTRA TECH Implant System, OsseoSpeed™ Profile Implant ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Subjects Treated With ASTRA TECH Implant System, OsseoSpeed™ Profile Implant |
|---|---|
| Age, Continuous | 49.05 years STANDARD_DEVIATION 13.974 |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 2 / 65 |
Outcome results
Primary
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
Time frame: At baseline and 16 weeks
Population: Per-protocol analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement | -0.02 mm | Standard Deviation 0.49 |
Secondary
Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement
Population: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | Permanent restoration to 12 months post implant placement | 0.02 CAL in mm | Standard Deviation 0.54 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | Permanent restoration to 24 months post implant placement | 0.14 CAL in mm | Standard Deviation 0.57 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | Permanent restoration to 36 months post implant placement | 0.11 CAL in mm | Standard Deviation 0.85 |
Secondary
Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement
Population: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | Permanent restoration to 12 months post implant placement | 0.28 PPD in mm | Standard Deviation 0.73 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | Permanent restoration to 24 months post implant placement | 0.31 PPD in mm | Standard Deviation 0.68 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | Permanent restoration to 36 months post implant placement | 0.36 PPD in mm | Standard Deviation 0.85 |
Secondary
Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.
Time frame: 21 weeks, 12 months, 24 months, and 36 months post implant placement
Population: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | Permanent restoration 21 weeks after implant placement | 2 Implants with BoP |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | 12 months after implant placement | 20 Implants with BoP |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | 24 months after implant placement | 16 Implants with BoP |
| Subjects Treated With OsseoSpeed™ Profile Implant | Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | 36 months after implant placement | 21 Implants with BoP |
Secondary
Implant Survival Rate
The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.
Time frame: 21 weeks, 12 months, 24 months and 36 months post implant placement.
Population: Per-protocol analysis set
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Implant Survival Rate | 65 Implants |
| Subjects Assessed at 12 Months Post Implant Placement | Implant Survival Rate | 64 Implants |
| Subjects Assessed at 24 Months Post Implant Placement | Implant Survival Rate | 59 Implants |
| Subjects Assessed at 36 Months Post Implant Placement | Implant Survival Rate | 57 Implants |
Secondary
Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.
Time frame: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement
Population: Per-protocol analysis set. All subjects/implants available for each visit are included in below analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Treated With OsseoSpeed™ Profile Implant | Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | Implant Placement to re-entry (implant placement + 16 weeks) | -0.28 mm | Standard Deviation 0.68 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | Implant placement to permanent restoration (implant placement + 21 weeks) | -0.48 mm | Standard Deviation 0.74 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | Implant placement to implant placement + 12 months | -0.29 mm | Standard Deviation 1.1 |
| Subjects Treated With OsseoSpeed™ Profile Implant | Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | Implant placement to implant placement + 36 months | -0.57 mm | Standard Deviation 1.6 |