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The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoDensification (OD) protocol | Experimental |
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| standard drilling (SD) protocol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoDensification (OD) protocol | Device | Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Ridge Width at Crest | bone ridge width will be measured using a Caliper | day of implant surgery |
| Change in Bone Ridge Width at 5mm Apical From Crest | bone ridge width will be measured using a Caliper | day of implant surgery |
| Change in Bone Ridge Width at 10mm Apical From Crest | bone ridge width will be measured using a Caliper | day of implant surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Stability of the Implants as Measured by the Insertion Torque Values | Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms). | day of implant surgery |
| Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Popi Stylianou, DDS,MS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
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15 participants were enrolled. Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoDensification (OD) Protocol | OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2023 |
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Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
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| standard drilling (SD) protocol (NobelReplace® Conical) | Device | osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant. |
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The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. |
| baseline(after implant placement) |
| Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | 3 weeks after implant placement |
| Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | 6 weeks after implant placement |
| Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | 12 weeks after implant placement |
| Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT) | 6 months post implantation |
| Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform | The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness. | 6 months post implantation |
| Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform | The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness. | 6 months post implantation |
| FG001 | Standard Drilling (SD) Protocol | standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Bone Ridge Width at Crest | bone ridge width will be measured using a Caliper | Posted | Mean | Standard Deviation | millimeters | day of implant surgery | Implants | Implants |
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| Primary | Change in Bone Ridge Width at 5mm Apical From Crest | bone ridge width will be measured using a Caliper | Posted | Mean | Standard Deviation | millimeters | day of implant surgery | Implants | Implants |
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| Primary | Change in Bone Ridge Width at 10mm Apical From Crest | bone ridge width will be measured using a Caliper | Posted | Mean | Standard Deviation | millimeters | day of implant surgery | Implants | Implants |
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| Secondary | Primary Stability of the Implants as Measured by the Insertion Torque Values | Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms). | Posted | Mean | Standard Deviation | Newton-centimeters | day of implant surgery | Implants | Implants |
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| Secondary | Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement) | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | Posted | Mean | Standard Deviation | score on a scale | baseline(after implant placement) | Implants | Implants |
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| Secondary | Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | Noting that some participants had multiple implants, data for 6 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 4 participants. Noting that some participants had multiple implants, data for 6 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 4 participants | Posted | Mean | Standard Deviation | score on a scale | 3 weeks after implant placement | Implants | Implants |
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| Secondary | Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | Noting that some participants had multiple implants, data for 6 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 4 participants. Noting that some participants had multiple implants, data for 6 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 4 participants | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after implant placement | Implants | Implants |
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| Secondary | Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement | The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability. | Data for 1 implant in the OsseoDensification (OD) protocol arm were not collected, including 1 participant for whom no implant data were collected. Data for 1 implant in the standard drilling (SD) protocol arm were not collected, including 1 participant for whom no implant data were collected. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks after implant placement | Implants | Implants |
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| Secondary | Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT) | Data were not collected for this outcome measure. | Posted | 6 months post implantation |
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| Secondary | Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform | The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness. | Noting that some participants had multiple implants, data for 3 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 2 participants. Noting that some participants had multiple implants, data for 3 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 2 participants | Posted | Mean | Standard Deviation | percent change | 6 months post implantation | Implants | Implants |
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| Secondary | Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform | The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness. | Noting that some participants had multiple implants, data for 3 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 2 participants. Noting that some participants had multiple implants, data for 3 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 2 participants | Posted | Mean | Standard Deviation | percent change | 6 months post implantation | Implants | Implants |
|
6 months
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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 | OsseoDensification (OD) Protocol | OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Standard Drilling (SD) Protocol | standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Popi Stylianou, DDS,MS | The University of Texas Health Science Center at Houston | 713-486-4048 | Popi.Stylianou@uth.tmc.edu |
| Oct 22, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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