An interventional study of OsseoDensification (OD) protocol and standard drilling (SD) protocol (NobelReplace® Conical) in Dental Implants, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: OsseoDensification (OD) protocol
Device: standard drilling (SD) protocol (NobelReplace® Conical)
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.
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.
Change in Bone Ridge Width at Crest
bone ridge width will be measured using a Caliper
Time frame: day of implant surgery
Change in Bone Ridge Width at 5mm Apical From Crest
bone ridge width will be measured using a Caliper
Time frame: day of implant surgery
Change in Bone Ridge Width at 10mm Apical From Crest
bone ridge width will be measured using a Caliper
Time frame: day of implant surgery
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).
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after implant placement
Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)
Time frame: 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.
Time frame: 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.
Time frame: 6 months post implantation
| Milestone | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
bone ridge width will be measured using a Caliper
| millimeters | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Change in Bone Ridge Width at Crest | 0.84 ± 0.59 | 0.01 ± 0.45 |
bone ridge width will be measured using a Caliper
| millimeters | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Change in Bone Ridge Width at 5mm Apical From Crest | 0.62 ± 0.65 | 0.11 ± 0.64 |
bone ridge width will be measured using a Caliper
| millimeters | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Change in Bone Ridge Width at 10mm Apical From Crest | 0.29 ± 0.76 | 0.01 ± 0.46 |
Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).
| Newton-centimeters | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Primary Stability of the Implants as Measured by the Insertion Torque Values | 57.7 ± 23.4 | 45 ± 25.5 |
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.
| score on a scale | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| 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) | 73.7 ± 7.23 | 67.0 ± 8.26 |
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.
| score on a scale | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| 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 | 75 ± 6.87 | 69.8 ± 7.99 |
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.
| score on a scale | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| 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 | 75.3 ± 6.16 | 70.8 ± 9.25 |
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.
| score on a scale | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| 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 | 76.8 ± 5.18 | 73.3 ± 7.31 |
No measurements were reported for this outcome.
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.
| percent change | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform | 6.24 ± 31.8 | -21.3 ± 20.3 |
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.
| percent change | OsseoDensification (OD) Protocol | Standard Drilling (SD) Protocol |
|---|---|---|
| Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform | 8.61 ± 25.3 | -15.1 ± 21.6 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OsseoDensification (OD) Protocol | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Standard Drilling (SD) Protocol | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 50.67 ± 14.80 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 9 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 15 |
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The University of Texas Health Science Center, Houston