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

S

Saint-Joseph University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Alveolar Bone Resorption

Treatments

Procedure: Guided bone regeneration

Study type

Interventional

Funder types

Other

Identifiers

NCT06523686
USJ-2023-57

Details and patient eligibility

About

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.

Full 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).

Enrollment

4 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

4 participants in 2 patient groups

Allogeneic-xenogeneic combination
Experimental group
Description:
A mix of 2/3 allogeneic bone with 1/3 xenogeneic bone
Treatment:
Procedure: Guided bone regeneration
Autogenous-xenogeneic combination
Experimental group
Description:
A mix of 2/3 autogenous bone and 1/3 xenogeneic bone
Treatment:
Procedure: Guided bone regeneration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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