Trial Outcomes & Findings for Osseodensification and Implant Survival and Success (NCT NCT04741594)

Last Updated: 2026-06-25

Results Overview

Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge. Not all measurements were able to be performed on each site due to anatomic limitations per site. Results were reported at 2 mm below the alveolar crest and 4 mm below the alveolar crest, when applicable. Measurements were performed by caliper measurements during the procedure and by CBCT followup approximately 3 months after implant placement

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Measurements were taken at baseline and 3 months after implant placement.

Results posted on

2026-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Patients to Receive a Dental Implant. All patients who met the inclusion criteria were enrolled. Those patients who were to receive an implant using the Versah bur, osseodensification technique were included.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients to Receive a Dental Implant. All patients who met the inclusion criteria were enrolled. Those patients who were to receive an implant using the Versah bur, osseodensification technique were included.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Osseodensification and Implant Survival and Success

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Receiving Implants. n=21 Participants Patients receiving implants using the technique of osseodensification to study the effects of healing on clinical parameters.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=20 Participants
Age, Categorical >=65 years	7 Participants n=20 Participants
Age, Continuous	58.8 years n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	14 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=20 Participants
Region of Enrollment United States	21 participants n=20 Participants

PRIMARY outcome

Timeframe: Measurements were taken at baseline and 3 months after implant placement.

Population: Bone width after implants.

Outcome measures

Outcome measures
Measure	Bone Width Measurements After Implants n=21 Participants The bone width measurements after implants were placed were measured at 2, 3, and 4mm. Results tables were created and reported for the 2 mm and 4 mm levels below the alveolar crest, where appropriate, due to anatomic constraints for each implant site. The data represent the mean change in bone width from the beginning of the procedure to the end of the procedure. Only the beginning and ending measurements were included for calculations and expressed as in the mean of bone change.
Bone Width (mm) 2 mm below crest	0.0769 Averaged change in width measured in mm Standard Deviation 0.4935
Bone Width (mm) 4 mm below crest	-0.1053 Averaged change in width measured in mm Standard Deviation 0.3153

SECONDARY outcome

Timeframe: From Initial Placement to 3 month follow-up - approximately 3 months

Population: Each implant site

Implant stability quotient (ISQ) values were performed at the time of implant placement and at the 3-month follow-up appointment, if possible. Osstell uses Resonance Frequency Analysis to determine implant stability. The result is presented as an ISQ (Implant Stability Quotient) value of 1-100. The higher the ISQ, the more stable the implant. Measure at implant placement for a baseline reading and again before final restoration.

Outcome measures

Outcome measures
Measure	Bone Width Measurements After Implants n=21 Participants The bone width measurements after implants were placed were measured at 2, 3, and 4mm. Results tables were created and reported for the 2 mm and 4 mm levels below the alveolar crest, where appropriate, due to anatomic constraints for each implant site. The data represent the mean change in bone width from the beginning of the procedure to the end of the procedure. Only the beginning and ending measurements were included for calculations and expressed as in the mean of bone change.
Change in Implant Stability	2.125 Scores on a scale from 1-100 Standard Deviation 5.8864

SECONDARY outcome

Timeframe: The extent of the study was approximately 3 months after implant placement. There is some small variability in the time frame for each implant placed based on scheduling of each patient.

Population: Number of implants that survived over time.

This outcome measure emphasizes the number of implants in this study that have survived for analysis.

Outcome measures

Outcome measures
Measure	Bone Width Measurements After Implants n=21 Participants The bone width measurements after implants were placed were measured at 2, 3, and 4mm. Results tables were created and reported for the 2 mm and 4 mm levels below the alveolar crest, where appropriate, due to anatomic constraints for each implant site. The data represent the mean change in bone width from the beginning of the procedure to the end of the procedure. Only the beginning and ending measurements were included for calculations and expressed as in the mean of bone change.
Number of Implants That Survived	20 number of implants that survived

Adverse Events

Implant Failure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Implant Failure n=21 participants at risk Implants sometimes do not heal correctly and are deemed a failure.
Product Issues Implant failure	0.00% 0/21 • 3 month No adverse events noted

Additional Information

Director of Graduate Periodontics Program

University of Oklahoma College of Dentistry

Phone: 4052718000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place