Trial Outcomes & Findings for A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft (NCT NCT01911819)

NCT ID: NCT01911819

Last Updated: 2017-12-13

Results Overview

Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 24months
• Results posted on: 2017-12-13

Participant Flow

The enrolled patients had either unilateral or bilateral maxillary sinus requiring maxillary sinus graft. For patients with bilateral sinus, each maxillary sinus was randomly assigned different treatment groups.

Unit of analysis: Maxillary Sinuses

Participant milestones

Measure	Sinus Augmentation Using Equimatrix Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using Bio-oss Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc
Overall Study STARTED	10 10	11 11	10 10
Overall Study COMPLETED	9 9	9 9	10 10
Overall Study NOT COMPLETED	1 1	2 2	0 0

Reasons for withdrawal

Measure	Sinus Augmentation Using Equimatrix Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using Bio-oss Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different.

Baseline characteristics by cohort

Measure	Sinus Augmentation Using Bio-oss n=9 Maxillary sinus Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using Equimatrix n=9 Maxillary sinus Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem n=10 Maxillary sinus Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc	Total n=28 Maxillary sinus Total of all reporting groups
Age, Continuous	60.9 years n=9 Maxillary sinus • The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different.	65.6 years n=9 Maxillary sinus • The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different.	57.9 years n=10 Maxillary sinus • The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different.	61.5 years n=28 Maxillary sinus • The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different.
Age, Customized Between 18 and 65 years	5 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	11 participants n=4 Participants
Age, Customized >=65 years	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants
Sex/Gender, Customized Female	5 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants
Sex/Gender, Customized Male	4 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	10 participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: 24months

Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

Outcome measures

Measure	Sinus Augmentation Using Bio-oss n=9 Maxillary sinuses Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using Equimatrix n=9 Maxillary sinuses Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem n=10 Maxillary sinuses Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc
The Percentage of Vital Bone in a Total Amount of a Bone Specimen	10.9 percentage of vital bone Standard Deviation 8.9	9.1 percentage of vital bone Standard Deviation 5.9	32.0 percentage of vital bone Standard Deviation 12.4

SECONDARY outcome

Timeframe: 24months

Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

Outcome measures

Measure	Sinus Augmentation Using Bio-oss n=9 Maxillary Sinuses Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using Equimatrix n=9 Maxillary Sinuses Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem n=10 Maxillary Sinuses Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc
The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.	34.3 percentage of residual bone materials Standard Deviation 12.1	38.9 percentage of residual bone materials Standard Deviation 5.3	5.5 percentage of residual bone materials Standard Deviation 5.7

Adverse Events

Sinus Augmentation Using Bio-oss

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sinus Augmentation Using Equimatrix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sinus Augmentation Using OSSIF-i Sem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sinus Augmentation Using Bio-oss n=11 participants at risk Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc)	Sinus Augmentation Using Equimatrix n=10 participants at risk Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)	Sinus Augmentation Using OSSIF-i Sem n=10 participants at risk Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc
Infections and infestations Maxillary sinus infection	9.1% 1/11 • Number of events 1 • Adverse event was monitored up to 2 weeks.	0.00% 0/10 • Adverse event was monitored up to 2 weeks.	0.00% 0/10 • Adverse event was monitored up to 2 weeks.

Additional Information

Prof. Joseph Kan

Loma Linda University

Phone: (909) 558-4980

Email: jkan@llu.edu

Results disclosure agreements

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