None listed
Conditions
Brief summary
Recently, an “All-on-4” (NobelBiocare) concept has been advocated as a possible solution for complete edentulous rehabilitation involving placement of full fixed acrylic bridgework immediately loaded on four implants located in the anterior mandible or maxilla of edentulous patients. This treatment modality has expanded the indication for dental implant therapy to include cases that otherwise could be contraindicated for implant-supported fixed prosthesis. Furthermore, the treatment concept is a very cost-effective rehabilitation for completely edentulous patients which make dental implant therapy affordable for a broader range of these patients.The aims of this clinical trial are to: · evaluate the success rate of ‘All-on-Four’ implant rehabilitation · Develop simplified surgical guides and prosthodontic techniques to allow accurate implant placement and provision of functional full arch rehabilitation immediately after implant placement. · Evaluate patients’ satisfaction before and after treatment. · Analyse the development of the microbial flora associated with this implant/prosthesis system · Relate the microbial flora to the health of the implant The hypothesis is: · The ‘All-on-Four’ implant rehabilitation will provide a high degree of patient satisfaction · The ‘All-on-Four’ implant rehabilitation will show high success values with respect to implant survival, and function and aesthetics of the prosthesis · Health of tissues surrounding an implant will be associated with a non-pathogenic bacterial flora.
Interventions
The latest technique for placing dental implants on edentulous patients (no teeth) is called All-on-Four, and this involves placing a full arch restoration fixed onto four implants in each jaw at the same day. The prospective study will involve the selection of 20 randomly selected patients (10 male and 10 female patients) who are edentulous in both maxilla and mandible. The patients will be followed for 3 years.
Sponsors
Nobelbiocare, Sweden
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be included in the study according to the following criteria:1.completely edentulous mandible and maxilla for at least one year2.rehabilitation with oral implants will be considered an elective procedure3.they are physically and medically able to tolerate conventional surgical and restorative procedures4.they agree to give signed informed consent5.they have adequate, good quality bone in both the mandible and maxilla6. all implants can be seated with a torque > 35Ncm and have initial primary stability.
Exclusion criteria
Patients to be excluded from the study include:1.the presence of pathological lesions, active infection or inflammation in the areas intended for implant placement2.history of a chronic smoking habit3.systemic diseases such as diabetes (all types, regardless of control)4.treatment with therapeutic radiation to the head within the past 12 months5.the need for bone augmentation at the intended implant site6.the presence of a previous unresorbed allograft at the implant site (as detected by radiographs)7.a habit of severe bruxism or clenching.
Outcome results
None listed