Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth

Study Overview
=================
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 To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA). 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. 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.

Official Title
-----------------
Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth

Conditions
-----------------
Edentulous Jaw, Dental Implant Failed

Intervention / Treatment
-----------------
* Procedure: Implant installation with PRF membrane
* Procedure: Implant installation without PRF membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will conduct a split-mouth design randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant installation with PRF<br>PRF membrane over the buccal aspect of implant site | Procedure: Implant installation with PRF membrane<br>* Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation<br>|
| Active Comparator: Implant installation without PRF<br>Implant installation contralateral to the the experimental implant, without PRF membrane | Procedure: Implant installation without PRF membrane<br>* Implant installation contralateral to the experimental side without PRF membrane<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized tissue thickness around implant neck | Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact | 6 months | 
| Keratinized tissue width around implant neck | Distance in mm of keratinized tissue from implant neck to mucogingival junction | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implants, platelet-rich plasm, edentulous jaw