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

Not Applicable

• Conditions: Edentulous Jaw; Dental Implant Failed
• Interventions: Procedure: Implant installation with PRF membrane; Procedure: Implant installation without PRF membrane

• Registration Number: NCT04429373
• Lead Sponsor: University of Chile

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.

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2020-11-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-22
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implant installation with PRF	Implant installation with PRF membrane	PRF membrane over the buccal aspect of implant site
Implant installation without PRF	Implant installation without PRF membrane	Implant installation contralateral to the the experimental implant, without PRF membrane

Primary Outcome Measures

Name	Time	Method
Implant stability	6 months	primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue width around implant neck	6 months	Distance in mm of keratinized tissue from implant neck to mucogingival junction
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

Trial Locations

Locations (1)

San Camilo Hospital; 🇨🇱 San Felipe, Aconcagua, Chile