Effect of L-PRF and A-PRF in Ridge Preservation

Study Overview
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Brief Summary
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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.

Official Title
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The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial

Conditions
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Atrophic Maxilla, Ridge Preservation

Intervention / Treatment
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* Other: L-PRF
* Other: A-PRF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-PRF<br>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<br>* 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.<br>|
| Experimental: A-PRF<br>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<br>* 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.<br>|
| No Intervention: Control<br>The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leucocyte- and platelet rich fibrin, ridge preservation, growth factors, platelet concentrates