Clinical trial NCT04429373: Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
Official title: Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Jaw
Dental Implant Failed
Keywords: dental implants
platelet-rich plasm
edentulous jaw
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a split-mouth design randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Implant stability
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue thickness around implant neck
timeFrame: 6 months
measure: Keratinized tissue width around implant neck
timeFrame: 6 months
Other outcomes:
Locations:
city: San Felipe
country: Chile
facility: San Camilo Hospital
state: Aconcagua
Study officials:
References: