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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft bone drilling protocol | Experimental | A soft bone drilling protocol will be used in bone quality 3 and 4 |
|
| Standard drilling protocol | Active Comparator | A standard drilling protocol will be used in bone quality 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed TX | Device | OsseoSpeed TX dental implants, 6-17 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Implant insertion and 12 months post implant insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Implant insertion and 3 months post implant insertion |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ruggero Rodriguez y Baena, Prof | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Associato Maffei | Bari | Italy | ||||
| Studio Dentistico Paolo Torrisi |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Group A + B | Subjects with implants from both Group A and Group B |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention to treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Soft Bone Drilling Protocol (Group B) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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". | Posted | Mean | Standard Deviation | mm | Implant insertion and 12 months post implant insertion | Implants | Implants |
|
From enrollment up to study termination, i.e., 1 year post implant insertion.
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Global Clinical Reseach | Dentsply Sirona Implants | +46313763500 | clinicalresearchmolndal@dentsplysirona.com |
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| 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. |
| 12 months after baseline, i.e., implant insertion |
| Implant Stability Assessed Clinically/Manually | Evaluated clinically/manually and recorded as stable yes/no. | At implant insertion |
| 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. | At implant insertion. |
| 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. | After implant insertion |
| 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. | After implant insertion |
| 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. | After implant insertion |
| Catania |
| 95125 |
| Italy |
| Societa diMedicina Odontostomatologica Srl | Como | 22100 | Italy |
| Dept. of Oral Sciences "S. Palazzi", University of Pavia | Pavia | 27100 | Italy |
| Studio Dentistico | Perugia | 06038 | Italy |
| La Scala & Partners Studio Associato | Pistoia | 51100 | Italy |
| Studio Odontoiatrico | Roma | 00192 | Italy |
| Studio Dentistico | Torino | 10143 | Italy |
| Studio Polispecialistico di Odontoiatria | Udine | 33100 | Italy |
A soft bone drilling protocol will be used in bone quality 3 and 4
OsseoSpeed TX: OsseoSpeed TX dental implants, 6-17 mm
| BG002 | Group A + B | Subjects with implants from both Group A and Group B |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 |
|
|
| 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. | 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". | Posted | Mean | Standard Deviation | mm | Implant insertion and 3 months post implant insertion | Implants | Implants |
|
|
|
| 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. | 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". | Posted | Count of Units | Implants | 12 months after baseline, i.e., implant insertion | Implants | Implants |
|
|
|
| Secondary | Implant Stability Assessed Clinically/Manually | Evaluated clinically/manually and recorded as stable yes/no. | ITT population. Outcome measure 4 is analyzed on implant level only and does not contain subject level group "Group A + B". | Posted | Count of Units | Implants | At implant insertion | Implants | 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. | ITT population. Outcome measure 5 is analyzed on implant level only and does not contain subject level group "Group A + B". | Posted | Mean | Standard Deviation | ISQ on implant level | At implant insertion. | Implants | Implants |
|
|
|
| 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. | ITT subjects. Outcome measure 6 is analyzed on implant level only and does not contain subject level group "Group A + B". | Posted | Mean | Standard Deviation | score on a scale | After implant insertion | Implants | Implants |
|
|
|
| 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. | ITT subjects. Outcome measure 7 is analyzed on implant level only and does not contain subject level group "Group A + B". | Posted | Mean | Standard Deviation | score on a scale | After implant insertion | implants | implants |
|
|
|
| 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. | ITT subjects. Outcome measure 8 is analyzed on implant level only and does not contain subject level group "Group A + B". | Posted | Mean | Standard Deviation | score on a scale | After implant insertion | implants | implants |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | 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 | 0 | 86 | 0 | 86 | 0 | 86 |
| EG002 | Group A + B | Subjects with implants from both Group A and Group B | 0 | 3 | 0 | 3 | 0 | 3 |
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| Male |
|