Effect of L-PRF and A-PRF in Ridge Preservation
The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
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
Study Start
First participant enrolled
August 22, 2015
CompletedFirst Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2018
CompletedOctober 11, 2018
October 1, 2018
3.1 years
August 28, 2017
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes horizontal width at crest -1mm
Primary outcome variables were defined as the changes in horizontal width at crest-1 mm levels.
3 months
Secondary Outcomes (1)
Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill
3 months
Other Outcomes (1)
Post-operative scores
1 week
Study Arms (3)
L-PRF
EXPERIMENTALOne socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.
A-PRF
EXPERIMENTALOne socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.
Control
NO INTERVENTIONThe socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.
Interventions
Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
Eligibility Criteria
You may qualify if:
- single-rooted teeth needed to be extracted in the upper jaw
- patient in good general health as documented by self-assessment
- patients must be committed to the study and must be willing to sing the informed consent.
You may not qualify if:
- any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- current pregnancy or breast feeding
- radiotherapy or chemotherapy in head and neck area
- intravenous and oral bisphosphonate
- patients smoking \>20 cig/day
- unwillingness to return for the follow-up examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana B Castro, PhD student
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral researcher
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 31, 2017
Study Start
August 22, 2015
Primary Completion
October 10, 2018
Study Completion
October 10, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share