Trial Outcomes & Findings for Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space (NCT NCT02387008)

Last Updated: 2019-09-25

Results Overview

Dimensional bone changes will assessed by calculating horizontal width and vertical height changes using data from DICOM images acquired by Cone beam computed tomography (CBCT).

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

6 months after treatment

Results posted on

2019-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	GUIDOR® Membrane With FDBA Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA	Bio-Gide® Membrane With FDBA Xenograft BioGide® membrane + Freeze-dried Bone Allograft (FDBA) Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA
Overall Study STARTED	2	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months after treatment

Population: Protocol-defined collection intervals were not achieved for any subjects enrolled; therefore, no data available for this measure.

Dimensional bone changes will assessed by calculating horizontal width and vertical height changes using data from DICOM images acquired by Cone beam computed tomography (CBCT).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days, 14 days, 28 days, 6 months

Population: No participants were randomized to the GUIDOR® Membrane Alone Arm

The presence or absence of soft tissue erythema within 3 mm from the crestal incision in the edentulous site will be visually assessed at post-operative evaluations.

Outcome measures

Outcome measures
Measure	GUIDOR® Membrane With FDBA n=2 Participants Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA	GUIDOR® Membrane Alone Horizontal bone augmentation with synthetic GUIDOR® membrane GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane	Bio-Gide® Membrane With FDBA n=4 Participants Xenograft BioGide® membrane + FDBA Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA
Inflammation Inflammation Present	0 Participants	0 Participants	0 Participants
Inflammation Inflammation Absent	2 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 7 days, 14 days, 28 days, 6 months

Population: No participants were randomized to the GUIDOR® Membrane Alone Arm

The presence or absence of infection in the area of ridge augmentation will be assessed through visual evaluation and palpation. The presence of suppuration from the crestal incision or soft tissues adjacent to the localized ridge augmentation will be assessed through visual evaluation. Fluctuance in the area of the augmentation will be assessed through gentle palpation of the surgical site.

Outcome measures

Outcome measures
Measure	GUIDOR® Membrane With FDBA n=2 Participants Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA	GUIDOR® Membrane Alone Horizontal bone augmentation with synthetic GUIDOR® membrane GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane	Bio-Gide® Membrane With FDBA n=4 Participants Xenograft BioGide® membrane + FDBA Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA
Infection Infection present	0 Participants	0 Participants	0 Participants
Infection Infection absent	2 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 7 days, 14 days, 28 days, 6 months

Population: No participants were randomized to the GUIDOR® Membrane Alone Arm

The presence of membrane exposure or soft tissue dehiscence will be visually assessed.

Outcome measures

Outcome measures
Measure	GUIDOR® Membrane With FDBA n=2 Participants Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA	GUIDOR® Membrane Alone Horizontal bone augmentation with synthetic GUIDOR® membrane GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane	Bio-Gide® Membrane With FDBA n=4 Participants Xenograft BioGide® membrane + FDBA Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA
Membrane Exposure membrane exposure or soft tissue dehiscencePresent	0 Participants	0 Participants	0 Participants
Membrane Exposure membrane exposure or soft tissue dehiscence Absent	2 Participants	0 Participants	4 Participants

Adverse Events

GUIDOR® Membrane With FDBA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GUIDOR® Membrane Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bio-Gide® Membrane With 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

Gidgetta Kang

University of North Carolina at Chapel Hill

Phone: 919-537-3968

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	GUIDOR® Membrane With FDBA n=2 Participants Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA	GUIDOR® Membrane Alone Horizontal bone augmentation with synthetic GUIDOR® membrane GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane	Bio-Gide® Membrane With FDBA n=4 Participants Xenograft BioGide® membrane + FDBA Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	3 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	—	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	—	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	4 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	—	4 Participants n=5 Participants	6 Participants n=4 Participants