Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
PRF
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2022
CompletedApril 22, 2021
April 1, 2021
1.7 years
June 9, 2020
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant stability
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
6 months
Secondary Outcomes (2)
Keratinized tissue thickness around implant neck
6 months
Keratinized tissue width around implant neck
6 months
Study Arms (2)
Implant installation with PRF
EXPERIMENTALPRF membrane over the buccal aspect of implant site
Implant installation without PRF
ACTIVE COMPARATORImplant installation contralateral to the the experimental implant, without PRF membrane
Interventions
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
Implant installation contralateral to the experimental side without PRF membrane
Eligibility Criteria
You may qualify if:
- mandibular edentulous
- \> 60 years old
You may not qualify if:
- physical or psychological impediment for dental surgery
- dental extraction \< 6 months in the mandible
- anticoagulant treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Camilo Hospital
San Felipe, Aconcagua, 969696, Chile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Allocation sequence will be masked from participant, outcome assessor and statistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 12, 2020
Study Start
November 30, 2020
Primary Completion
July 31, 2022
Study Completion
December 20, 2022
Last Updated
April 22, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share