Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth (PRF)
Primary Purpose
Edentulous Jaw, Dental Implant Failed
Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Implant installation with PRF membrane
Implant installation without PRF membrane
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw focused on measuring dental implants, platelet-rich plasm, edentulous jaw
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
Sites / Locations
- San Camilo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Implant installation with PRF
Implant installation without PRF
Arm Description
PRF membrane over the buccal aspect of implant site
Implant installation contralateral to the the experimental implant, without PRF membrane
Outcomes
Primary Outcome Measures
Implant stability
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
Secondary Outcome Measures
Keratinized tissue thickness around implant neck
Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact
Keratinized tissue width around implant neck
Distance in mm of keratinized tissue from implant neck to mucogingival junction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429373
Brief Title
Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
Acronym
PRF
Official Title
Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw, Dental Implant Failed
Keywords
dental implants, platelet-rich plasm, edentulous jaw
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will conduct a split-mouth design randomized clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Allocation sequence will be masked from participant, outcome assessor and statistician
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implant installation with PRF
Arm Type
Experimental
Arm Description
PRF membrane over the buccal aspect of implant site
Arm Title
Implant installation without PRF
Arm Type
Active Comparator
Arm Description
Implant installation contralateral to the the experimental implant, without PRF membrane
Intervention Type
Procedure
Intervention Name(s)
Implant installation with PRF membrane
Intervention Description
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
Intervention Type
Procedure
Intervention Name(s)
Implant installation without PRF membrane
Intervention Description
Implant installation contralateral to the experimental side without PRF membrane
Primary Outcome Measure Information:
Title
Implant stability
Description
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Keratinized tissue thickness around implant neck
Description
Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact
Time Frame
6 months
Title
Keratinized tissue width around implant neck
Description
Distance in mm of keratinized tissue from implant neck to mucogingival junction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franco Cavalla, DDS PhD
Phone
+56932035746
Email
icavalla@odontologia.uchile.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Patricio Neira, DDS
Phone
+56995193394
Email
pneira@odontologia.uchile.cl
Facility Information:
Facility Name
San Camilo Hospital
City
San Felipe
State/Province
Aconcagua
ZIP/Postal Code
969696
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricio Neira, DDS
Phone
(34) 249 3200
Email
patricioneiraguerra@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcelo Tejedor, DDS
Phone
(34) 249 3200
Email
marcelo.tejedor@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
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