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Completed

NCT Number: NCT06523686

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Saint Joseph university

Beirut, 00000, Lebanon

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Guided bone regeneration

Procedure

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.

Primary outcomes

  1. Linear bone width changes

    Time frame: 6 months

    Linear bone width changes assessed clinically and radiographically in mm

  2. Volumetric bone changes

    Time frame: 6 months

    Volumetric bone changes assessed radiographically in cubic mm

Secondary outcomes

  1. Clinical Ridge Height gain

    Time frame: 6 months

    Clinical Ridge Height gain in mm

  2. Probe penetration

    Time frame: 6 months

    Probe penetration at the occlusion-buccal angle

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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