NCT04376060

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

Completed NA Results posted Last updated 12 October 2020

What this trial tests

NA trial testing Gen-Os®; The soft lamina (OsteoBiol®) in Horizontal Ridge Deficiency in 15 participants. Completed in 31 January 2019.

Timeline

4 April 2017

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Saint-Joseph University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	4 April 2017
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across Lebanon

Drugs / interventions tested

• Gen-Os®; The soft lamina (OsteoBiol®)

Conditions studied

• Horizontal Ridge Deficiency — all drugs for Horizontal Ridge Deficiency →

Sponsor

Saint-Joseph University

Who can join

Adults 27 to 64, any sex, with Horizontal Ridge Deficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Radiological Bone Width Augmentation at 0 mm Primary · Six months after 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).

Group	Value	95% CI
Study Population	2.274	± 1.517

Change From Baseline in Radiological Bone Width Augmentation at 2 mm Primary · Six months after 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.

Group	Value	95% CI
Study Population	2.274	± 1.015

Change From Baseline in Radiological Bone Width Augmentation at 4 mm Primary · Six months after 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.

Group	Value	95% CI
Study Population	2.028	± 0.79

Change From Baseline in Radiological Bone Width Augmentation at 6 mm Primary · Six months after 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.

Group	Value	95% CI
Study Population	1.442	± 0.929

Number of Implants Placed at 6 Months From the Regeneration Procedure Secondary · Six months after the regeneration procedure

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

Group	Value	95% CI
Study Population	26

Change From Baseline in Radiological Bone Height Augmentation in mm Measured Buccally Secondary · 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

Group	Value	95% CI
Study Population	2.776	± 2.445

Bone Percentage Superficially Secondary · Six months after the regeneration procedure

The percentage of bone in the superficial cuts

Group	Value	95% CI
Study Population	60.781	± 11.629

Change From Baseline in Radiological Bone Height Augmentation in mm Measured Medially Secondary · 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

Group	Value	95% CI
Study Population	0.812	± 0.905

Change From Baseline in Radiological Bone Height Augmentation in mm Measured Lingually Secondary · 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

Group	Value	95% CI
Study Population	0.734	± 0.812

Bone Percentage Medially Secondary · Six months after the regeneration procedure

The percentage of bone in the median cuts

Group	Value	95% CI
Study Population	73.616	± 14.136

Bone Percentage in the Deep Cuts Secondary · Six months after the regeneration procedure

The percentage of bone in the deep cuts

Group	Value	95% CI
Study Population	77.234	± 7.183

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Population

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Study Population
Bone Regeneration Failure	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT04376060 adverse events section.

Sponsor's own description

The primary aim of this study is to clinically, radiographically and histologically evaluate the lateral bone augmentation of the soft porcine cortical lamina (OsteoBiol®) using equine-derived bone particles (OsteoBiol®)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.