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

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.

Study Overview

• Status: Completed
• Conditions: Ridge Preservation; Atrophic Maxilla
• Intervention / Treatment: Other: L-PRF; Other: A-PRF

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 3 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: L-PRF; One 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.	Other: L-PRF; 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.
EXPERIMENTAL: A-PRF; One 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.	Other: A-PRF; 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.
NO_INTERVENTION: Control; The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill	Changes in horizontal width at crest -3 mm and 5 mm; vertical resorption at the lingual and buccal side; socket fill.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative scores	Post-operative discomfort measured with VAS	1 week

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ana B Castro, PhD student, UZ Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2015
• Primary Completion (ACTUAL): October 10, 2018
• Study Completion (ACTUAL): October 10, 2018

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): August 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: platelet concentrates; growth factors; ridge preservation; leucocyte- and platelet rich fibrin
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: B322201525149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No