Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membraneHorizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane
Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane: Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being fixed with non-resorbable pins (Test Group).
Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane: Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being left unfixed (Control Group).
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)
Horizontal Bone Gain — T3: 6 months after the Horizontal GBR 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 GBR to facilitate implant placement at 6 months.
Along the 6 months, 3 Cone Beam Computed Tomography scans (CBCT) will be needed. At baseline (T1), the first CBCT will be taken before performing any surgical procedure to measure the initial width of the ridge. Immediately after the GBR (T2), a second CBCT scan will be taken, which will be useful to measure new ridge width in each group. Finally, at 6 month follow-up a third CBCT scan will be taken (T3) in order to assess the difference with T1 regarding amount of bone gain horizontally, and with T2 regarding horizontal dimensional stability of the grafted bone in each of the 2 groups.
Bone Width Gain — T3: 6 months after the Horizontal GBR To compare the bone width gain between the test group and control group, 6 months after the horizontal GBR.
A caliper will be used in order to evaluate and compare the bone width gain at T1, T2, and T3 between the Test and Control Groups. These measurements are performed intra-operatively before the Horizontal GBR (T1), immediately after (T2), and at 6 months (T3) at the time of implant placement. Measurements will be performed at 1cm, 3cm, and 5cm apical from the bone crest at the regenerated area.
Trial sites (1)
Facility
City
Region
Status
Georgios Markantonatos
Barcelona
Sant Cugat Del Vallès
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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