Trial Outcomes & Findings for The Horizontal Ridge Augmentation Using Equine Xenograft and a Collagenated Porcine Cortical Lamina (NCT NCT04376060)

NCT ID: NCT04376060

Last Updated: 2020-10-12

Results Overview

Width difference measured at the top of the crest (0 mm) at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at top of the crest (0 mm).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Six months after the regeneration procedure

Results posted on

2020-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Study Population Patients who complied with the inclusion criteria of this study and received the procedure of horizontal bone augmentation.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Population Patients who complied with the inclusion criteria of this study and received the procedure of horizontal bone augmentation.
Overall Study Physician Decision	1

Baseline Characteristics

The Horizontal Ridge Augmentation Using Equine Xenograft and a Collagenated Porcine Cortical Lamina

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Population n=14 Participants Patients who received the intervention of horizontal bone augmentation using the cortical lamina and the equine-derived bone particles,
Age, Continuous	48.2 years STANDARD_DEVIATION 11.7 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Horizontal bone augmentation at 0 mm	2.989 mm STANDARD_DEVIATION 1.612 • n=93 Participants

PRIMARY outcome

Timeframe: Six months after the regeneration procedure

Population: 14 patients who have had the regeneration procedure

Width difference measured at the top of the crest (0 mm) at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at top of the crest (0 mm).

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Width Augmentation at 0 mm	2.274 mm Standard Deviation 1.517

PRIMARY outcome

Timeframe: Six months after the regeneration procedure

Population: 14 patients who have had the regeneration procedure

Width difference measured at 2 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 2 mm of the top of the crest.

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Width Augmentation at 2 mm	2.274 mm Standard Deviation 1.015

PRIMARY outcome

Timeframe: Six months after the regeneration procedure

Population: 14 patients who have had the regeneration procedure

Width difference measured at 4 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 4 mm of the top of the crest.

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Width Augmentation at 4 mm	2.028 mm Standard Deviation 0.79

PRIMARY outcome

Timeframe: Six months after the regeneration procedure

Population: 14 patients who have had the regeneration procedure

Width difference measured at 6 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 6 mm of the top of the crest.

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Width Augmentation at 6 mm	1.442 mm Standard Deviation 0.929

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

Number of implants placed in the regenerated areas at 6 months from the regeneration procedure

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Number of Implants Placed at 6 Months From the Regeneration Procedure	26 Implants

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

Height difference measured buccally in mm at the site of implant placement, measured over superimposition of pre-operative Cone Beam Computed Tomography (baseline) and post-operative Cone Beam Computed Tomography (at 6 months) The value measured at 6 months minus the value measured at baseline = height difference measured buccally

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Height Augmentation in mm Measured Buccally	2.776 mm Standard Deviation 2.445

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

The percentage of bone in the superficial cuts

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Bone Percentage Superficially	60.781 percentage of bone tissue Standard Deviation 11.629

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

Height difference measured medially in mm at the site of implant placement, measured over superimposition of pre-operative Cone Beam Computed Tomography (baseline) and post-operative Cone Beam Computed Tomography (at 6 months) The value measured at 6 months minus the value measured at baseline = height difference measured medially

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Height Augmentation in mm Measured Medially	0.812 mm Standard Deviation 0.905

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

Height difference measured lingually in mm at the site of implant placement, measured over superimposition of pre-operative Cone Beam Computed Tomography (baseline) and post-operative Cone Beam Computed Tomography (at 6 months) The value measured at 6 months minus the value measured at baseline = height difference measured lingually

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Change From Baseline in Radiological Bone Height Augmentation in mm Measured Lingually	0.734 mm Standard Deviation 0.812

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

The percentage of bone in the median cuts

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Bone Percentage Medially	73.616 percentage of bone tissue Standard Deviation 14.136

SECONDARY outcome

Timeframe: Six months after the regeneration procedure

The percentage of bone in the deep cuts

Outcome measures

Outcome measures
Measure	Study Population n=14 Participants Fourteen patients (1 male, 13 females) aged between 27 and 64 years old
Bone Percentage in the Deep Cuts	77.234 percentage of bone tissue Standard Deviation 7.183

Adverse Events

Study Population

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Population n=15 participants at risk Patients who complied with the inclusion criteria of this study and received the procedure of horizontal bone augmentation.
Injury, poisoning and procedural complications Bone Regeneration Failure	6.7% 1/15 • Number of events 1 • 6 months The risk of Serious Adverse Events and All-Cause Mortality after Guided Bone Regeneration in healthy patients is null when the practitioner has made a thorough investigation of the medical history of the patient. This is not a life-threatening procedure

Additional Information

Dr Sarah Khalil

Saint Joseph University

Phone: 0096170322739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place