Trial Outcomes & Findings for Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts (NCT NCT03769376)

Results Overview

The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline to 16-20 weeks

Results posted on

2021-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	Bio-Oss® Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Salvin-Oss® Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Overall Study STARTED	20	18
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex/Gender demographics information was not collected for any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bio-Oss® n=20 Participants Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Salvin-Oss® n=18 Participants Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Total n=38 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=38 Participants
Age, Customized Between 18 and 100 years	20 Participants n=20 Participants	18 Participants n=18 Participants	38 Participants n=38 Participants
Sex: Female, Male Female	—	—	0 Participants Sex/Gender demographics information was not collected for any participant.
Sex: Female, Male Male	—	—	0 Participants Sex/Gender demographics information was not collected for any participant.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	18 participants n=18 Participants	38 participants n=38 Participants

PRIMARY outcome

Timeframe: Baseline to 16-20 weeks

Population: Only participants that completed the study are included in the analysis.

The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.

Outcome measures

Outcome measures
Measure	Bio-Oss® n=13 Participants Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Salvin-Oss® n=11 Participants Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks Vital bone	29.38 Percent Interval 14.07 to 54.91	32.05 Percent Interval 16.53 to 60.63
New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks Residual graft	14.02 Percent Interval 5.32 to 22.3	16.56 Percent Interval 5.95 to 50.16
New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks Connective Tissue/other	56.61 Percent Interval 39.74 to 78.51	51.39 Percent Interval 20.35 to 69.57

PRIMARY outcome

Timeframe: Baseline to 16-20 weeks

Population: Only participants that completed the study are included in the analysis.

The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported

Outcome measures

Outcome measures
Measure	Bio-Oss® n=13 Participants Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Salvin-Oss® n=11 Participants Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks	15.38 Percent Interval 0.0 to 100.0	9.09 Percent Interval 0.0 to 100.0

Adverse Events

Bio-Oss®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Salvin-Oss®

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

Kerri Font, DDS, MS

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place