Standard Implants With Bone Regeneration vs Short Implants
NCT ID: NCT03524885
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-01-08
2019-12-31
Brief Summary
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The hypothesis of the study is that both treatment options will be successful to rehabilitate atrophic posterior mandibles or maxillae. Moreover, more surgical complications will be encountered in the bone regeneration group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short implants
2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden \& Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.
Short implant placement
Ten patients will be randomly selected for the short implants option, 2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden \& Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.
After three months an acrylic screw-retained bridge will be delivered. After further three months, a definitive restauration with a metal ceramic bridge will be seated.
Bone regeneration with longer implants
A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US).
The graft will be composed half autogenous bone harvested with a scraper (Meta, Firenze, Italy) by the same surgical site or by a second tunnel site in the mandibular ramus and half deproteinized bovine bone (Bio Oss Geislicht Pharma, Switzerland). The mucosal flaps will be sutured in a double layer with horizontal mattress and single gore-tex sutures (Cytoplast PTFE sutures 3.0, Cytoplast Osteogenics, US).
2 or 3 implant from 10 to 13 mm length putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.
Bone regeneration with longer implants
Ten patients will be randomly assigned to the regenerative group, 2 or 3 implant from 10 to 13 mm length intentionally exposed putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.
A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US).
Interventions
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Short implant placement
Ten patients will be randomly selected for the short implants option, 2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden \& Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.
After three months an acrylic screw-retained bridge will be delivered. After further three months, a definitive restauration with a metal ceramic bridge will be seated.
Bone regeneration with longer implants
Ten patients will be randomly assigned to the regenerative group, 2 or 3 implant from 10 to 13 mm length intentionally exposed putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.
A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US).
Eligibility Criteria
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Inclusion Criteria
* All patients with at least 3 mm of keratinized tissue on the edentulous crest. In case of absence of this prerequisite, three months before the keratinized tissue is augmented by a ephytelium-connective tissue graft harvested from the palate.
* Patients with edentulous distal sites
Exclusion Criteria
* Patients with active periodontal disease: full mouth plaque index (FMPI \> 20%) and Full mouth bleeding index (FMBI \> 20%).
* Patients with less of 5 mm of bone width.
* Patients with systemic conditions or under prescription of medications that contraindicate oral surgery
18 Years
ALL
Yes
Sponsors
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University of Valencia
OTHER
Responsible Party
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David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
Locations
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Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H1506438508468
Identifier Type: -
Identifier Source: org_study_id
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