Dental Implants
Conditions
Keywords
osseodensification, ridge expansion
Brief summary
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
Interventions
DEVICEOsseoDensification (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.
DEVICEstandard 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who understand and agree to this study. * Adequate Oral hygiene * One or more edentulous spaces, which are 10 weeks or longer after extractions
Exclusion criteria
* Pregnancy. * Smoking of more than 5 cigarettes/day. * History of alcoholism or drug abuse during the last 5 years. * Uncontrolled Hypertension or diabetes. * Patient with malignant tumor. * Patients on daily dose of steroids. * Patients with history of chemotherapy or radiation for the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Ridge Width at Crest | day of implant surgery | bone ridge width will be measured using a Caliper |
| Change in Bone Ridge Width at 5mm Apical From Crest | day of implant surgery | bone ridge width will be measured using a Caliper |
| Change in Bone Ridge Width at 10mm Apical From Crest | day of implant surgery | bone ridge width will be measured using a Caliper |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Primary Stability of the Implants as Measured by the Insertion Torque Values | day of implant surgery | Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms). |
| Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform | 6 months post implantation | 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 of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform | 6 months post implantation | 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. |
| Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT) | 6 months post implantation | — |
| 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) | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 50.67 years STANDARD_DEVIATION 14.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) Protocol | Change in Bone Ridge Width at 10mm Apical From Crest | 0.29 millimeters | Standard Deviation 0.76 |
| Standard Drilling (SD) Protocol | Change in Bone Ridge Width at 10mm Apical From Crest | 0.01 millimeters | Standard Deviation 0.46 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) Protocol | Change in Bone Ridge Width at 5mm Apical From Crest | 0.62 millimeters | Standard Deviation 0.65 |
| Standard Drilling (SD) Protocol | Change in Bone Ridge Width at 5mm Apical From Crest | 0.11 millimeters | Standard Deviation 0.64 |
Primary
Change in Bone Ridge Width at Crest
bone ridge width will be measured using a Caliper
Time frame: day of implant surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) Protocol | Change in Bone Ridge Width at Crest | 0.84 millimeters | Standard Deviation 0.59 |
| Standard Drilling (SD) Protocol | Change in Bone Ridge Width at Crest | 0.01 millimeters | Standard Deviation 0.45 |
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.
Time frame: 6 months post implantation
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) 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 percent change | Standard Deviation 31.8 |
| 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 | -21.3 percent change | Standard Deviation 20.3 |
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.
Time frame: 6 months post implantation
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) Protocol | Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform | 8.61 percent change | Standard Deviation 25.3 |
| 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 | -15.1 percent change | Standard Deviation 21.6 |
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.
Time frame: 12 weeks after implant placement
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) 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 score on a scale | Standard Deviation 5.18 |
| 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 | 73.3 score on a scale | Standard Deviation 7.31 |
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.
Time frame: 3 weeks after implant placement
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) 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 score on a scale | Standard Deviation 6.87 |
| 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 | 69.8 score on a scale | Standard Deviation 7.99 |
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.
Time frame: 6 weeks after implant placement
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) 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 score on a scale | Standard Deviation 6.16 |
| 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 | 70.8 score on a scale | Standard Deviation 9.25 |
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.
Time frame: baseline(after implant placement)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) 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 score on a scale | Standard Deviation 7.23 |
| 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) | 67.0 score on a scale | Standard Deviation 8.26 |
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).
Time frame: day of implant surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoDensification (OD) Protocol | Primary Stability of the Implants as Measured by the Insertion Torque Values | 57.7 Newton-centimeters | Standard Deviation 23.4 |
| Standard Drilling (SD) Protocol | Primary Stability of the Implants as Measured by the Insertion Torque Values | 45 Newton-centimeters | Standard Deviation 25.5 |
Secondary
Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)
Time frame: 6 months post implantation
Population: Data were not collected for this outcome measure.