Lateral Ridge Augmentation Using Two Graft Combination and a Cross-linked Collagen Membrane

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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Guided bone regeneration

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 00000
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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%.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allogeneic-xenogeneic combination; A mix of 2/3 allogeneic bone with 1/3 xenogeneic bone	Procedure: Guided bone regeneration; Compare the linear and volumetric bone width changes, clinically and radiographically, between two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal GBR.
Experimental: Autogenous-xenogeneic combination; A mix of 2/3 autogenous bone and 1/3 xenogeneic bone	Procedure: Guided bone regeneration; Compare the linear and volumetric bone width changes, clinically and radiographically, between two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal GBR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear bone width changes	Linear bone width changes assessed clinically and radiographically in mm	6 months
Volumetric bone changes	Volumetric bone changes assessed radiographically in cubic mm	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Ridge Height gain	Clinical Ridge Height gain in mm	6 months
Probe penetration	Probe penetration at the occlusion-buccal angle	6 months

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Celine Rassi, DDS, Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: USJ-2023-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No