Trial Outcomes & Findings for Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol (NCT NCT05283928)

Results Overview

bone ridge width will be measured using a Caliper

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

day of implant surgery

Results posted on

2024-11-29

Participant Flow

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

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15 20	15 20
Overall Study COMPLETED	15 20	15 20
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 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.
Age, Continuous	50.67 years STANDARD_DEVIATION 14.80 • n=15 Participants
Sex: Female, Male Female	9 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: day of implant surgery

bone ridge width will be measured using a Caliper

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=20 Implants 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.	Standard Drilling (SD) Protocol n=20 Implants 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.
Change in Bone Ridge Width at Crest	0.84 millimeters Standard Deviation 0.59	0.01 millimeters Standard Deviation 0.45

PRIMARY outcome

Timeframe: day of implant surgery

bone ridge width will be measured using a Caliper

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=20 Implants 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.	Standard Drilling (SD) Protocol n=20 Implants 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.
Change in Bone Ridge Width at 5mm Apical From Crest	0.62 millimeters Standard Deviation 0.65	0.11 millimeters Standard Deviation 0.64

PRIMARY outcome

Timeframe: day of implant surgery

bone ridge width will be measured using a Caliper

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=20 Implants 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.	Standard Drilling (SD) Protocol n=20 Implants 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.
Change in Bone Ridge Width at 10mm Apical From Crest	0.29 millimeters Standard Deviation 0.76	0.01 millimeters Standard Deviation 0.46

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=20 Implants 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.	Standard Drilling (SD) Protocol n=20 Implants 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.
Primary Stability of the Implants as Measured by the Insertion Torque Values	57.7 Newton-centimeters Standard Deviation 23.4	45 Newton-centimeters Standard Deviation 25.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=20 Implants 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.	Standard Drilling (SD) Protocol n=20 Implants 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.
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	67.0 score on a scale Standard Deviation 8.26

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=14 Implants 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.	Standard Drilling (SD) Protocol n=14 Implants 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.
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	69.8 score on a scale Standard Deviation 7.99

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=14 Implants 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.	Standard Drilling (SD) Protocol n=14 Implants 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.
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	70.8 score on a scale Standard Deviation 9.25

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=19 Implants 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.	Standard Drilling (SD) Protocol n=19 Implants 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.
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	73.3 score on a scale Standard Deviation 7.31

SECONDARY outcome

Timeframe: 6 months post implantation

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=17 Implants 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.	Standard Drilling (SD) Protocol n=17 Implants 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.
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	-21.3 percent change Standard Deviation 20.3

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	OsseoDensification (OD) Protocol n=17 Implants 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.	Standard Drilling (SD) Protocol n=17 Implants 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.
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	-15.1 percent change Standard Deviation 21.6

Adverse Events

OsseoDensification (OD) Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Drilling (SD) Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Popi Stylianou, DDS,MS

The University of Texas Health Science Center at Houston

Phone: 713-486-4048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place