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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523686
Enrollment
4
Registered
2024-07-26
Start date
2023-01-09
Completion date
2024-07-10
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Resorption

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).

Interventions

PROCEDUREGuided 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.

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Volumetric bone changes6 monthsVolumetric bone changes assessed radiographically in cubic mm
Linear bone width changes6 monthsLinear bone width changes assessed clinically and radiographically in mm

Secondary

MeasureTime frameDescription
Clinical Ridge Height gain6 monthsClinical Ridge Height gain in mm
Probe penetration6 monthsProbe penetration at the occlusion-buccal angle

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026