Comparing two types of collagen membranes for bone regeneration
Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes: A Randomized Controlled Clinical Trial
This study is testing whether using fixed or non-fixed collagen membranes helps people with narrow jawbones gain more bone for dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Barcelona, Sant Cugat Del Vallès) |
| Trial ID | NCT06334159 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of fixed versus non-fixed resorbable collagen membranes in promoting horizontal bone gain during Guided Bone Regeneration (GBR) procedures. Participants will receive a mixture of xenograft and allograft as a bone substitute, with one group using fixed membranes and the other using non-fixed membranes. The primary outcome will be measured at six months post-treatment, focusing on the amount of bone gained to facilitate dental implant placement. The study is designed to provide insights into which membrane type yields better results in patients with insufficient ridge width.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with insufficient ridge width for dental implants and good oral hygiene.
Not a fit: Patients with sufficient ridge width or those requiring more complex surgical techniques will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients requiring dental implants by identifying the more effective collagen membrane for bone regeneration.
How similar studies have performed: Previous studies have shown varying success with different types of collagen membranes in GBR, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona, Sant Cugat Del Vallès
- Georgios Markantonatos — Barcelona, Sant Cugat Del Vallès, Spain (Recruiting)
Study contacts
- Principal investigator: Cristina Vallés, DDS, MS, PhD — Universitat Internacional de Catalunya
- Study coordinator: Georgios Markantonatos, DDS
- Email: giorgosmark@uic.es
- Phone: +34666022568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.