Trial Outcomes & Findings for Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift. (NCT NCT02865590)

NCT ID: NCT02865590

Last Updated: 2020-03-23

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Lyophilized Equine Bone Allograft Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)	Deproteinized Bovine Bone Allograft Sinus lift with deproteinized bovine bone allograft Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lyophilized Equine Bone Allograft n=8 Participants Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)	Deproteinized Bovine Bone Allograft n=8 Participants Sinus lift with deproteinized bovine bone allograft Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 6.00 • n=5 Participants	51 years STANDARD_DEVIATION 6.00 • n=7 Participants	51 years STANDARD_DEVIATION 6.00 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Italy	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Caucasion patients aged ≥ 25 years with at least one atrophic posterior maxilla (distally from first bicuspid teeth) with a residual crest height ≤4 mm who need sinus lift augmentation for dental implant placement were eligible for the study.

Outcome measures

Outcome measures
Measure	Lyophilized Equine Bone Allograft n=8 Participants Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)	Deproteinized Bovine Bone Allograft n=8 Participants Sinus lift with deproteinized bovine bone allograft Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
Histomorphometric Evaluation of New Bone Formation. marrow spaces	50.77 percentage of millimeters Standard Deviation 7.59	46.20 percentage of millimeters Standard Deviation 14.30
Histomorphometric Evaluation of New Bone Formation. newly formed bone	22.20 percentage of millimeters Standard Deviation 7.18	22.84 percentage of millimeters Standard Deviation 7.34
Histomorphometric Evaluation of New Bone Formation. residual graft material	27 percentage of millimeters Standard Deviation 6.75	30.94 percentage of millimeters Standard Deviation 10.20

Adverse Events

Lyophilized Equine Bone Allograft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deproteinized Bovine Bone Allograft

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

Enrico Marchetti DDS, PhD

Department MESVA - University of L'Aquila

Phone: +39862433304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place