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

Dental Implant Failed Clinical Trial

— PRF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429373
• Other study ID #: ORF42004
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: April 2021
• Source: University of Chile
• Contact: Franco Cavalla, DDS PhD
• Phone: +56932035746
• Email: icavalla[@]odontologia.uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed
• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• Implant installation with PRF membrane
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
• Implant installation without PRF membrane
Implant installation contralateral to the experimental side without PRF membrane

Locations

Country	Name	City	State
Chile	San Camilo Hospital	San Felipe	Aconcagua

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability	primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).	6 months
Secondary	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
Secondary	Keratinized tissue width around implant neck	Distance in mm of keratinized tissue from implant neck to mucogingival junction	6 months