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

Phase 2

Completed

• Conditions: Alveolar Bone Resorption

• Registration Number: NCT06523686
• Lead Sponsor: Saint-Joseph University

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).

Study Timeline

• Study Start: 2023-01-09
• Primary Completion: 2024-06-10
• Status Verified: 2024-07
• Study Completion: 2024-07-10
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Linear bone width changes	6 months	Linear bone width changes assessed clinically and radiographically in mm
Volumetric bone changes	6 months	Volumetric bone changes assessed radiographically in cubic mm

Secondary Outcome Measures

Name	Time	Method
Probe penetration	6 months	Probe penetration at the occlusion-buccal angle
Clinical Ridge Height gain	6 months	Clinical Ridge Height gain in mm

Trial Locations

Locations (1)

Saint Joseph university; 🇱🇧 Beirut, Lebanon