Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes

Universitat Internacional de Catalunya

Status: Enrolling

Conditions: Bone Resorption

Treatments: Procedure: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane; Procedure: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT06334159

PER-ECL-2019-08

Details and patient eligibility

About

The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Full description

The aim of this clinical trial is to compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women over 18 years old or older
2. Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) to place dental implants, with sufficient vertical ridge height (≥9mm) from vital anatomical structures (the inferior alveolar nerve in the Mandible, or the sinus in the Maxilla)
3. One or more teeth missing in posterior zone (Premolars, and Molars)
4. Absence of active Periodontal disease
5. Good level of oral hygiene (Plaque index <25%)
6. Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)
7. Non smokers or light smokers (<10 cigarettes per day)
8. Informed consent signed

Exclusion criteria

1. Patients with sufficient ridge width (>5 mm) and height (≥9mm) from vital anatomical structure) requiring no GBR to place dental implants
2. Patients with severe horizontal and vertical defects requiring other surgical techniques.
3. Long-term non-steroidal anti-inflammatory drug therapy (3months).
4. Lactating females or currently pregnant women.
5. Severe cognitive or psychiatric disorders.
6. Unwillingness to return for follow-up examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Control Group

Experimental group

Description:

Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with non-fixed resorbable collagen membranes (Jason Membrane 20x30mm)

Treatment:

Procedure: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane

Test Group

Experimental group

Description:

Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with fixed resorbable collagen membranes(Jason Membrane 20x30mm) with the use of pins (Titan Pins)

Treatment:

Procedure: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane