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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-07-10

Brief Summary

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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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Detailed Description

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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).

Conditions

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Alveolar Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allogeneic-xenogeneic combination

A mix of 2/3 allogeneic bone with 1/3 xenogeneic bone

Group Type EXPERIMENTAL

Guided bone regeneration

Intervention Type 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.

Autogenous-xenogeneic combination

A mix of 2/3 autogenous bone and 1/3 xenogeneic bone

Group Type EXPERIMENTAL

Guided bone regeneration

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes