Postextraction alveolar ridge preservation: biological basis and treatments.
Giorgio Pagni, Gaia Pellegrini, William V Giannobile...
https://pubmed.ncbi.nlm.nih.gov/22737169Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06334159
Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes: A Randomized Controlled Clinical Trial
Led by Universitat Internacional de Catalunya · Updated on 2024-03-27
26
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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 membranes—one 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 50/50 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
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Georgios Markantonatos
Barcelona, Sant Cugat Del Vallès, Spain, 08195
Actively Recruiting
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Research Team
G
Georgios Markantonatos, DDS
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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Sang-Woon Lee, Seong-Gon Kim
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Rozalia Dimitriou, George I Mataliotakis, Giorgio Maria Calori...
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Istvan A Urban, Jaime L Lozada, Bastian Wessing...
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Alessandro Cucchi, Elisabetta Vignudelli, Aldo Napolitano...
https://pubmed.ncbi.nlm.nih.gov/28745035Clinical evaluation of a ridge augmentation procedure for the severely resorbed alveolar socket: multicenter randomized controlled trial, preliminary results.
Angelo Sisti, Luigi Canullo, Maria Pia Mottola...
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