Edentulism
Conditions
Brief summary
This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.
Detailed description
This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.
Interventions
DEVICEOsseoSpeed TX
OsseoSpeed TX dental implants, 6-17 mm
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Female/male aged 18 years and over 3. History of edentulism in the study area of at least 3 months 4. At least 4 months healing after last grafting procedure in the study area 5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47 6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition. 7. Deemed by the investigator to be suitable for one stage surgery 8. Deemed by the investigator to be suitable for immediate loading 9. Deemed by the investigator as likely to present an initially stable implant situation. 10. Deemed by the investigator to have a functional opposing dentition at the time of loading the implants.
Exclusion criteria
1. Unlikely to be able to comply with study procedures, as judged by the investigator 2. Uncontrolled pathological processes in the oral cavity 3. Known or suspected current malignancy 4. History of radiation therapy in the head and neck region 5. History of chemotherapy within 5 years prior to surgery 6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration 7. Uncontrolled diabetes mellitus 8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration 9. Present alcohol and/or drug abuse 10. Current need for bone grafting and/or augmentation in the planned implant area 11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 12. Previous enrolment in the present study. 13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Change | Implant insertion and 12 months post implant insertion | Marginal Bone Level alterations will be 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 12 months after baseline, i.e., implant insertion | Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading. |
| Implant Stability Assessed Clinically/Manually | At implant insertion | Evaluated clinically/manually and recorded as stable yes/no. |
| Implant Stability Using Resonance Frequency Analysis (RFA) | At implant insertion. | The Osstell® instrument Osstell® ISQ will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability. |
| Marginal Bone Level Change | Implant insertion and 3 months post implant insertion | Marginal Bone Level alterations will be 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. |
| Perception During Implant Insertion - The Implant Followed the Prepared Osteotomy | After implant insertion | After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement. |
| Perception During Implant Insertion - The Implant Has a Good Primary Stability | After implant insertion | After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement. |
| Perception During Implant Insertion - The Implant Was Guided Into the Prepared Osteotomy | After implant insertion | After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Drilling Protocol (Group A) A standard drilling protocol will be used in bone quality 1 and 2
OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm | 79 |
| Soft Bone Drilling Protocol (Group B) A soft bone drilling protocol will be used in bone quality 3 and 4
OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm | 86 |
| Group A + B Subjects with implants from both Group A and Group B | 3 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Implant failure | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 | 0 |
Baseline characteristics
| Characteristic | Standard Drilling Protocol (Group A) | Soft Bone Drilling Protocol (Group B) | Group A + B | Total |
|---|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 12.6 | 47.5 Years STANDARD_DEVIATION 12.3 | 54.3 Years STANDARD_DEVIATION 17.7 | 47.2 Years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 44 Participants | 3 Participants | 90 Participants |
| Sex: Female, Male Male | 36 Participants | 42 Participants | 0 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 86 | 0 / 3 |
| other Total, other adverse events | 0 / 79 | 0 / 86 | 0 / 3 |
| serious Total, serious adverse events | 0 / 79 | 0 / 86 | 0 / 3 |
Outcome results
Primary
Marginal Bone Level Change
Marginal Bone Level alterations will be 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.
Time frame: Implant insertion and 12 months post implant insertion
Population: ITT subjects with MBL data available (MBL data missing for 14 implants in Group A, and from 10 implants in group B). Outcome measure 1 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Marginal Bone Level Change | -0.25 mm | Standard Deviation 0.9 |
| Soft Bone Drilling Protocol (Group B) | Marginal Bone Level Change | -0.2 mm | Standard Deviation 0.67 |
Secondary
Implant Stability Assessed Clinically/Manually
Evaluated clinically/manually and recorded as stable yes/no.
Time frame: At implant insertion
Population: ITT population. Outcome measure 4 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Implant Stability Assessed Clinically/Manually | Implant stability - Yes | 86 Implants |
| Standard Drilling Protocol (Group A) | Implant Stability Assessed Clinically/Manually | Implant stability - No | 0 Implants |
| Soft Bone Drilling Protocol (Group B) | Implant Stability Assessed Clinically/Manually | Implant stability - Yes | 97 Implants |
| Soft Bone Drilling Protocol (Group B) | Implant Stability Assessed Clinically/Manually | Implant stability - No | 5 Implants |
Secondary
Implant Stability Using Resonance Frequency Analysis (RFA)
The Osstell® instrument Osstell® ISQ will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability.
Time frame: At implant insertion.
Population: ITT population. Outcome measure 5 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Drilling Protocol (Group A) | Implant Stability Using Resonance Frequency Analysis (RFA) | Bucco-Palatinal | 78.8 ISQ on implant level | Standard Deviation 5.9 |
| Standard Drilling Protocol (Group A) | Implant Stability Using Resonance Frequency Analysis (RFA) | Mesio-Distal | 78.6 ISQ on implant level | Standard Deviation 6.2 |
| Soft Bone Drilling Protocol (Group B) | Implant Stability Using Resonance Frequency Analysis (RFA) | Bucco-Palatinal | 77.7 ISQ on implant level | Standard Deviation 9.4 |
| Soft Bone Drilling Protocol (Group B) | Implant Stability Using Resonance Frequency Analysis (RFA) | Mesio-Distal | 77.5 ISQ on implant level | Standard Deviation 9.6 |
Secondary
Implant Survival Rate
Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.
Time frame: 12 months after baseline, i.e., implant insertion
Population: ITT subjects at 12 months as well as known implant failures already terminated are included in the analysis.~Outcome measure 3 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Implant Survival Rate | Implants confirmed success | 82 Implants |
| Standard Drilling Protocol (Group A) | Implant Survival Rate | Implants confirmed failure | 2 Implants |
| Soft Bone Drilling Protocol (Group B) | Implant Survival Rate | Implants confirmed success | 94 Implants |
| Soft Bone Drilling Protocol (Group B) | Implant Survival Rate | Implants confirmed failure | 4 Implants |
Secondary
Marginal Bone Level Change
Marginal Bone Level alterations will be 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.
Time frame: Implant insertion and 3 months post implant insertion
Population: ITT subjects with MBL data available (MBL data missing from 10 implants in Group A, from 9 implants in group B). Outcome measure 2 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Marginal Bone Level Change | -0.2 mm | Standard Deviation 0.62 |
| Soft Bone Drilling Protocol (Group B) | Marginal Bone Level Change | -0.29 mm | Standard Deviation 0.67 |
Secondary
Perception During Implant Insertion - The Implant Followed the Prepared Osteotomy
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion
Population: ITT subjects. Outcome measure 7 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Perception During Implant Insertion - The Implant Followed the Prepared Osteotomy | 8.2 score on a scale | Standard Deviation 1.6 |
| Soft Bone Drilling Protocol (Group B) | Perception During Implant Insertion - The Implant Followed the Prepared Osteotomy | 7.6 score on a scale | Standard Deviation 2 |
Secondary
Perception During Implant Insertion - The Implant Has a Good Primary Stability
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion
Population: ITT subjects. Outcome measure 8 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Perception During Implant Insertion - The Implant Has a Good Primary Stability | 8.7 score on a scale | Standard Deviation 1.3 |
| Soft Bone Drilling Protocol (Group B) | Perception During Implant Insertion - The Implant Has a Good Primary Stability | 8.1 score on a scale | Standard Deviation 1.7 |
Secondary
Perception During Implant Insertion - The Implant Was Guided Into the Prepared Osteotomy
After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements The implant was guided into the prepared osteotomy, The implant followed the prepared osteotomy and The implant has a good primary stability. The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Time frame: After implant insertion
Population: ITT subjects. Outcome measure 6 is analyzed on implant level only and does not contain subject level group Group A + B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Drilling Protocol (Group A) | Perception During Implant Insertion - The Implant Was Guided Into the Prepared Osteotomy | 7.5 score on a scale | Standard Deviation 2.6 |
| Soft Bone Drilling Protocol (Group B) | Perception During Implant Insertion - The Implant Was Guided Into the Prepared Osteotomy | 7.1 score on a scale | Standard Deviation 2.4 |