Standard Implants With Bone Regeneration vs Short Implants
- Conditions
- Bone ResorptionImplant Complication
- Interventions
- Procedure: Bone regeneration with longer implantsProcedure: Short implant placement
- Registration Number
- NCT03524885
- Lead Sponsor
- University of Valencia
- Brief Summary
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to compare, considering different parameters, the rehabilitation with dental implants of atrophic posterior mandibles or maxillae using short implants or longer implants with vertical bone regeneration with GBR.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- All the patients with a distal edentulism Kennedy -Applegate Class II in the posterior mandible or maxilla, with residual bone height from the top of the crest to the opposite landmark (the alveolar nerve for the lower and the sinus cavity for the upper) between 5 and 7 millimeters. The bone peak on the last tooth before the edentulous space must be positioned from 2 to 4 mm from the CEJ. (X-ray evaluation by periapical film on a Rinn Holder).
- 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
- Heavy smokers (more than 10 cigarettes /day)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bone regeneration with longer implants 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. Short implants Short implant placement 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.
- Primary Outcome Measures
Name Time Method Peri-implant bone level changes 12 months after implant loading Interproximal bone level measured on a periapical film taken with a Rinn Holder
- Secondary Outcome Measures
Name Time Method Implant survival rate 12 months after implant loading % of implants in function
Patient satisfaction 12 months after implant loading by means a Visual Analogue Scale ranging between 0 (lowest) and 10 (highest)
Trial Locations
- Locations (1)
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
🇪🇸Valencia, Spain