Trial Outcomes & Findings for Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft (NCT NCT01924390)

NCT ID: NCT01924390

Last Updated: 2014-10-06

Results Overview

Bone core biopsy will be evaluated histologically for percent new vital bone formation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: 18-20 weeks
• Results posted on: 2014-10-06

Participant Flow

Participant milestones

Measure	Mineralized FDBA Alone Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Combination of Mineralized and Demineralized FDBA Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Overall Study STARTED	22	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft

Baseline characteristics by cohort

Measure	Mineralized FDBA Alone n=22 Participants Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Combination of Mineralized and Demineralized FDBA n=22 Participants Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone	Total n=44 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	53 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18-20 weeks

Bone core biopsy will be evaluated histologically for percent new vital bone formation

Outcome measures

Measure	Mineralized FDBA Alone n=21 Participants Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Combination of Mineralized and Demineralized FDBA n=21 Participants Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Percent New Vital Bone Formation	24.7 percentage of vital bone Standard Deviation 16.0	36.2 percentage of vital bone Standard Deviation 11.9

SECONDARY outcome

Timeframe: 18-20 weeks

Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue

Outcome measures

Measure	Mineralized FDBA Alone n=21 Participants Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Combination of Mineralized and Demineralized FDBA n=21 Participants Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Percent Residual Graft Material and Percent Connective Tissue	27.0 percentage of residual graft Standard Deviation 13.6	18.2 percentage of residual graft Standard Deviation 12.4

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of implant placement, which is 18-20 weeks after grafting of extraction socket

Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.

Outcome measures

Measure	Mineralized FDBA Alone n=21 Participants Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Combination of Mineralized and Demineralized FDBA n=21 Participants Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Change in Ridge Width and Ridge Height	1.63 change in ridge width (loss of width mm) Standard Deviation 1.18	1.19 change in ridge width (loss of width mm) Standard Deviation 1.36

Adverse Events

Mineralized FDBA Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination of Mineralized and Demineralized FDBA

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

Brian L. Mealey

UTHSCSA Periodontics

Phone: 210-567-3589

Email: mealey@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place