Effect of Platelet-rich Plasm (PRF) on Two-implant Mandib... | NCT04429373

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

NCT04429373

Sponsor

University of Chile

Status

Unknown status

Last Update Posted

Apr 22, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Edentulous Jaw
Dental Implant Failed

Interventions

Implant installation with PRF membrane
Implant installation without PRF membrane

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2020Actual

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Jun 9, 2020

First Submission Date that Met QC Criteria

Jun 10, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2021

Last Update Posted Date

Apr 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implant installation with PRF	Experimental	PRF membrane over the buccal aspect of implant site	Procedure: Implant installation with PRF membrane
Implant installation without PRF	Active Comparator	Implant installation contralateral to the the experimental implant, without PRF membrane	Procedure: Implant installation without PRF membrane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implant installation with PRF membrane	Procedure	Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation	Implant installation with PRF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Keratinized tissue width around implant neck

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Franco Cavalla, DDS PhD	Contact	+56932035746		icavalla@odontologia.uchile.cl
Patricio Neira, DDS	Contact	+56995193394		pneira@odontologia.uchile.cl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Camilo Hospital	Recruiting	San Felipe	Aconcagua	969696	Chile

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007575	Jaw, Edentulous

Ancestor Terms

ID	Term
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases
D009066	Mouth, Edentulous

Browse Leaves

Not provided

Browse Branches

Not provided