Comparing Fixed and Non-Fixed Resorbable Collagen Membranes for Guided Bone Regeneration to Help Dental Implant Placement
Led by Universitat Internacional de Catalunya · Updated on 2024-03-27
26
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating horizontal bone gain in patients with resorbed ridges needing Guided Bone Regeneration GBR to support dental implant placement. This clinical trial compares two methods of using resorbable collagen membranesone group receives non-fixed membranes, while the other group receives fixed membranes secured with pins. The goal is to see which method better supports bone growth over a 6-month period after treatment.
Participants receive horizontal GBR using a bone graft made from a 5050 mix of xenograft and allograft bone substitutes. One group has the collagen membrane placed without fixation control, while the other group has the membrane fixed with non-resorbable pins test group. Both procedures involve covering the graft area with a Jason membrane measuring 20x30 mm. The study is randomized and compares the outcomes between these two approaches.
During the study, participants will undergo assessments including measurement of horizontal bone gain and bone width gain at 6 months post-procedure. Other evaluations include checking the stability of the bone dimensions, monitoring any post-surgical complications from surgery up to 6 months, assessing patient satisfaction two weeks after surgery, and conducting histologic examination of the augmented bone at implant placement. The study is sponsored by the Universitat Internacional de Catalunya and participation may last about 6 months with follow-up visits and evaluations.
CONDITIONS
Brief Title
Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes
Research Team
G
Georgios Markantonatos, DDS
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Patients requiring Guided Bone Regeneration due to ridge width of 5 mm or less and sufficient vertical ridge height of 9 mm or more
One or more missing teeth in the premolar or molar areas
Absence of active periodontal disease
Good oral hygiene with plaque index less than 25%
No systemic diseases that could affect therapy outcome (e.g., uncontrolled diabetes, osteoporosis, bisphosphonate use)
Non-smokers or light smokers (fewer than 10 cigarettes per day)
Signed informed consent
You will not qualify if you...
Patients with sufficient ridge width (greater than 5 mm) and height (9 mm or more) not needing Guided Bone Regeneration
Patients with severe horizontal and vertical bone defects requiring other surgical techniques
Long-term use of non-steroidal anti-inflammatory drugs for 3 months or more
Pregnant or lactating women
Severe cognitive or psychiatric disorders
Unwillingness to return for follow-up visits
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - 1 day
Participants undergo Horizontal Guided Bone Regeneration using either fixed or non-fixed resorbable collagen membranes with a mixture of bone graft materials to augment the bone for future implant placement.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - 6 months
Participants are monitored for post-surgical complications and recovery after the bone regeneration surgery.
Approximately 6 post-operative visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical evaluation of a ridge augmentation procedure for the severely resorbed alveolar socket: multicenter randomized controlled trial, preliminary results.
Evaluation of complication rates and vertical bone gain after guided bone regeneration with non-resorbable membranes versus titanium meshes and resorbable membranes. A randomized clinical trial.
Vertical Bone Grafting and Periosteal Vertical Mattress Suture for the Fixation of Resorbable Membranes and Stabilization of Particulate Grafts in Horizontal Guided Bone Regeneration to Achieve More Predictable Results: A Technical Report.
Istvan A Urban, Jaime L Lozada, Bastian Wessing...