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

University of Chile

Status: Unknown

Conditions: Edentulous Jaw; Dental Implant Failed

Treatments: Procedure: Implant installation without PRF membrane; Procedure: Implant installation with PRF membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT04429373

ORF42004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Implant installation with PRF

Experimental group

Description:

PRF membrane over the buccal aspect of implant site

Treatment:

Procedure: Implant installation with PRF membrane

Implant installation without PRF

Active Comparator group

Description:

Implant installation contralateral to the the experimental implant, without PRF membrane

Treatment:

Procedure: Implant installation without PRF membrane