Dental Implant Failed, Edentulous Jaw
Conditions
Keywords
dental implants, platelet-rich plasm, edentulous jaw
Brief summary
Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key. Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults. The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.
Detailed description
The investigators will conduct a split-mouth design randomized clinical trial assessing the effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in edentulous elderly adults. Aim and purpose 1. To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA). 2. To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients. 3. To examine soft tissues volumetric changes pre and post- surgery using intraoral scans and bone changes using cone-beam computed tomography (CBCT) around mandibular implants in edentulous patients.
Interventions
PROCEDUREImplant installation with PRF membrane
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
PROCEDUREImplant installation without PRF membrane
Implant installation contralateral to the experimental side without PRF membrane
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Allocation sequence will be masked from participant, outcome assessor and statistician
Intervention model description
We will conduct a split-mouth design randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* mandibular edentulous * \> 60 years old
Exclusion criteria
* physical or psychological impediment for dental surgery * dental extraction \< 6 months in the mandible * anticoagulant treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | 6 months | primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized tissue thickness around implant neck | 6 months | Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact |
| Keratinized tissue width around implant neck | 6 months | Distance in mm of keratinized tissue from implant neck to mucogingival junction |
Countries
Chile
Contacts
Primary ContactFranco Cavalla, DDS PhD
Backup ContactPatricio Neira, DDS
Outcome results
None listed