Skip to main content
Clinical Trials/NCT06523686
NCT06523686
Completed
Phase 2

Lateral Ridge Augmentation Using Autogenous-xenogeneic or Allogeneic-xenogeneic Graft Mix With a Cross-linked Collagen Membrane: a Randomized Pilot Clinical Trial

Saint-Joseph University1 site in 1 country4 target enrollmentJanuary 9, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Alveolar Bone Resorption
Sponsor
Saint-Joseph University
Enrollment
4
Locations
1
Primary Endpoint
Linear bone width changes
Status
Completed
Last Updated
last year

Overview

Brief Summary

To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.

Detailed Description

Bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. Different types of membranes and bone grafts are used in the GBR procedure. However, there is a lack of studies in the literature about the combination allograft/xenograft. The aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).

Registry
clinicaltrials.gov
Start Date
January 9, 2023
End Date
July 10, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saint-Joseph University
Responsible Party
Principal Investigator
Principal Investigator

Celine Rassi

Periodontology resident

Saint-Joseph University

Eligibility Criteria

Inclusion Criteria

  • Healthy patients, non-smokers or smokers \<10 cigarettes/day.
  • Age between 20 and
  • Full mouth bleeding score (FmBS) \<20 %.
  • Full mouth plaque score (FmPS) \<15%.
  • 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.

Exclusion Criteria

  • Systemic diseases.
  • Heavy smokers (\> 10 cigarettes/day).
  • History of radiotherapy in the head and neck region in the last 5 years.
  • Active periodontitis on the remaining teeth.
  • Pregnancy.
  • 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).

Outcomes

Primary Outcomes

Linear bone width changes

Time Frame: 6 months

Linear bone width changes assessed clinically and radiographically in mm

Volumetric bone changes

Time Frame: 6 months

Volumetric bone changes assessed radiographically in cubic mm

Secondary Outcomes

  • Clinical Ridge Height gain(6 months)
  • Probe penetration(6 months)

Study Sites (1)

Loading locations...

Similar Trials