Lateral Ridge Augmentation Using Cross-linked or Non-cross-linked Collagen Membrane

NCT04402671 | Completed

• 1 other identifier: FMD188
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present trial is to test clinically, radiographically and histologically , in a lateral alveolar ridge augmentation model (without simultaneous implant placement) the efficiency in supporting bone formation of a glutaraldehyde cross-linked collagen membrane compared to a non-cross-linked collagen membrane with the use of a composite autograft-xenograft mix prepared in a 1:3 ratio

Conditions

Bone Loss

Keywords

Guided bone regeneration; collagen membrane; crosslinked collagen membrane; Bone augmentation

Outcome Measures

Primary Outcomes (1)

• Linear measurements outcomes

  the ridge mapping changes in linear measurements between initial ridge width and reentry ridge width at 1, 3 and 5 mm from the ridge crest

  6 - 9 months

Secondary Outcomes (9)

• Volumetric measurements outcome

  6 - 9 months

• the percentage of graft volume resorption.

  6 - 9 months

• Linear measurements outcomes on DICOM data

  6 - 9 months

• Soft tissue healing

  6 - 9 months

• Periodontal Probe Penetration (PP)

  6 - 9 months

Study Arms (2)

non-crosslinked collagen membrane group

ACTIVE COMPARATOR

2 patients (1 male, 1 female)

Other: non-cross-linked porcine skin collagen membrane

glutaraldehyde cross-linked collagen membrane

ACTIVE COMPARATOR

2 patients (2 females)

Other: glutaraldehyde cross-linked bovine collagen membrane

Interventions

non-cross-linked porcine skin collagen membrane OTHER

non-cross-linked porcine skin collagen membrane used is Bioguide, Geistlisch Pharma AG, Wolhusen, Switzerland.

Also known as: Bioguide

non-crosslinked collagen membrane group

glutaraldehyde cross-linked bovine collagen membrane OTHER

glutaraldehyde cross-linked bovine collagen membrane GCLM used is RTM Collagen®, Osteogenics Biomedical, Lubbock, TX, USA.

Also known as: Cytoplast RTM

glutaraldehyde cross-linked collagen membrane

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients, non-smokers or smokers\<10 cigarettes/day.
• Age between 20 and 75.
• Full mouth bleeding score (FmBS) \<20 %.
• Full mouth plaque score (FmPS) \<15%.
• Presence of a residual alveolar ridge with residual bone width \< 5 mm and adequate
• bone height in the maxilla and the mandible.
• Tooth extraction performed at least 6 weeks before surgery.
• Presence of enough teeth to support an occlusal stent/radiographic guide.

You may not qualify if:

• Systematic diseases.
• History of radiotherapy in the head and neck region in the last 5 years.
• Active periodontitis on the remaining teeth.
• Pregnancy.
• Allergy to collagen.
• Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Mario Haddad

Beirut, 1200, Lebanon

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carole F Chakar, PhD

  Saint-Joseph University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients are blind to the allocation. The radiographic volumetric changes and the histomorphometrical analysis are assessed by blind examiners. Random allocation was done by the sequentially sealed envelope method. At the time of membrane placement during the surgery, the envelope corresponding to the case sequence number is opened specifying the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a pilot randomized clinical trial with parallel groups, with an observation period of 6 - 9 months. It is set to identify the equivalence between the test and the control procedures. An equal randomization is set for the 2 groups

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 27, 2020
• Study Start: March 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as the study is published
• Access Criteria: A scientific journal

Locations

LE (1)