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

NCT04376060 | Completed Results

• 1 other identifier: FMD 141
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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®)

Conditions

Horizontal Ridge Deficiency

Keywords

osteogenesis; xenograft; membrane

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Radiological Bone Width Augmentation at 0 mm

  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).

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Width Augmentation at 2 mm

  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.

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Width Augmentation at 4 mm

  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.

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Width Augmentation at 6 mm

  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.

  Six months after the regeneration procedure

Secondary Outcomes (7)

• Number of Implants Placed at 6 Months From the Regeneration Procedure

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Height Augmentation in mm Measured Buccally

  Six months after the regeneration procedure

• Bone Percentage Superficially

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Height Augmentation in mm Measured Medially

  Six months after the regeneration procedure

• Change From Baseline in Radiological Bone Height Augmentation in mm Measured Lingually

  Six months after the regeneration procedure

Study Arms (1)

Study population

EXPERIMENTAL

Fifteen patients (1 male, 14 females) aged between 27 and 64 years old

Device: Gen-Os®; The soft lamina (OsteoBiol®)

Interventions

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

The xenograft used in this study was the Gen-Os® by OsteoBiol; as described by the manufacturer, it is a carbonated nanocrystal bone mineral and collagen of natural heterologous origin, obtained by the treatment of cortical bone tissue of equine origins. Its granulometry ranges between 0.25 to 1 mm and it is described as being slightly radiopaque. The soft lamina (OsteoBiol®) used is a 35x35mm medium curved membrane of porcine origins. Its clinical indications as described by the fabricator: a co-adjuvant for the reconstruction or the partial or complete recovery of lost bone portions, fillers of non-infected, non-sclerotic and well blood bedewed bone defects.

Study population

Eligibility Criteria

• Age: 27 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systematically healthy
• good oral hygiene (FMPS and FMBS \<20%).
• having ridges with deficiencies in width (\<4 mm, Cawood and Howell class IV) which did not allow correct implant placement.

You may not qualify if:

• pregnant and lactating women,
• patients suffering from a systematic disease
• patients on bisphosphonates
• smokers (\>10 cigarettes/day)
• patients needing vertical augmentations

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Sarah Khalil

Beirut, 1200, Lebanon

Location

Related Publications (3)

• Rossi R, Rancitelli D, Poli PP, Rasia Dal Polo M, Nannmark U, Maiorana C. The use of a collagenated porcine cortical lamina in the reconstruction of alveolar ridge defects. A clinical and histological study. Minerva Stomatol. 2016 Oct;65(5):257-68.

  PMID: 27580650 BACKGROUND

• Deepika-Penmetsa SL, Thomas R, Baron TK, Shah R, Mehta DS. Cortical lamina technique: A therapeutic approach for lateral ridge augmentation using guided bone regeneration. J Clin Exp Dent. 2017 Jan 1;9(1):e21-e26. doi: 10.4317/jced.53008. eCollection 2017 Jan.

  PMID: 28149458 BACKGROUND

• Wachtel H, Fickl S, Hinze M, Bolz W, Thalmair T. The bone lamina technique: a novel approach for lateral ridge augmentation--a case series. Int J Periodontics Restorative Dent. 2013 Jul-Aug;33(4):491-7. doi: 10.11607/prd.1248.

  PMID: 23820709 BACKGROUND

Limitations and Caveats

Technical problems with histomorphometric measurements: the distinction between pre-existent and newly formed bone was not possible in all the histological cuts

Results Point of Contact

• Title: Dr Sarah Khalil
• Organization: Saint Joseph University

sarahfkhalil2@gmail.com

0096170322739

Study Officials

• Carole Chakar, PhD

  Saint-Joseph University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Fourteen patients (1 male, 13 females) aged between 27 and 64 years old were selected from the Department of Periodontology of the Faculty of Dentistry, Saint Joseph University Beirut.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 6, 2020
• Study Start: April 4, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: October 12, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as the study is published (summer 2020)
• Access Criteria: Publication in a scientific journal

Locations

LE (1)