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

Last updated: March 20, 2024
Sponsor: Universitat Internacional de Catalunya
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Density

Treatment

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

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

Clinical Study ID

NCT06334159
PER-ECL-2019-08
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women over 18 years old or older
  2. Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) toplace dental implants, with sufficient vertical ridge height (≥9mm) from vitalanatomical structures (the inferior alveolar nerve in the Mandible, or the sinus inthe 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

Exclusion Criteria:

  1. Patients with sufficient ridge width (>5 mm) and height (≥9mm) from vital anatomicalstructure) requiring no GBR to place dental implants
  2. Patients with severe horizontal and vertical defects requiring other surgicaltechniques.
  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.

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane
Phase:
Study Start date:
November 05, 2020
Estimated Completion Date:
July 20, 2027

Study 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.

Connect with a study center

  • Georgios Markantonatos

    Barcelona, Sant Cugat Del Vallès 08195
    Spain

    Active - Recruiting

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