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

NCT ID: NCT04429373

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Edentulous Jaw Dental Implant Failed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will conduct a split-mouth design randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Allocation sequence will be masked from participant, outcome assessor and statistician

Study Groups

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Implant installation with PRF

PRF membrane over the buccal aspect of implant site

Group Type EXPERIMENTAL

Implant installation with PRF membrane

Intervention Type PROCEDURE

Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation

Implant installation without PRF

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

Group Type ACTIVE_COMPARATOR

Implant installation without PRF membrane

Intervention Type PROCEDURE

Implant installation contralateral to the experimental side without PRF membrane

Interventions

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Implant installation with PRF membrane

Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation

Intervention Type PROCEDURE

Implant installation without PRF membrane

Implant installation contralateral to the experimental side without PRF membrane

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Franco Cavalla

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Camilo Hospital

San Felipe, Aconcagua, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Franco Cavalla, DDS PhD

Role: CONTACT

+56932035746

Patricio Neira, DDS

Role: CONTACT

+56995193394

Facility Contacts

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Patricio Neira, DDS

Role: primary

(34) 249 3200

Marcelo Tejedor, DDS

Role: backup

(34) 249 3200

Other Identifiers

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ORF42004

Identifier Type: -

Identifier Source: org_study_id

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