Clinical trial NCT06334159: Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes
Official title: Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group)
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Horizontal Bone Gain
timeFrame: T3: 6 months after the Horizontal GBR
measure: Bone Width Gain
timeFrame: T3: 6 months after the Horizontal GBR
Secondary outcomes:
measure: Horizontal Dimensional Stability
timeFrame: T3: 6 months after the Horizontal GBR
measure: Post-surgical complications
timeFrame: T2-T3: From the surgery to 6 months
measure: Patient's satisfaction
timeFrame: At 2-weeks follow up after the surgical procedure
measure: Histologic examination of the augmented bone at 6 months
timeFrame: At time of implant placement
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Georgios Markantonatos
state: Sant Cugat Del Vallès
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Cristina Vallés, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
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