- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387913
Evaluation of the Effect of Leucocyte Platelet-Rich Fibrin (L-PRF) Technique Applied in Post-extraction Sockets Before Placement of Dental Implants
Aim of study: The application of L-PRF membrane in post-extraction sockets outmatches the use of a) allograft covered with a collagen fleece b) allograft combined with L-PRF membrane c) natural healing, with reference to bone remodeling and regeneration of post-extraction sockets.
Moreover, it will be examined whether the application of L-PRF membrane leads to faster bone maturation and creation of a favorable biological environment for earlier implant placement.
Materials and methods: This study is taking place in Athens University Dental School, in Oral and Maxillofacial Surgery Clinic. All patients participating in the present study received thorough informed consent. All forty patients participating in this study, were subjected in at least one atraumatic and flapless extraction of a single rooted tooth in the maxilla or mandible. Then, the patients were randomly divided in four categories with regards to management of the socket: a) no intervention i.e. Natural healing b) application of L-PRF membrane in the socket c) application of allograft (Phoenix) covered with a collagen fleece d) application of allograft (Phoenix) covered with a L-PRF membrane. Interrupted sutures will be performed for the four extraction socket groups.
Radiographic examination (localized CBCT) was obtained immediately before the extraction, as well as three months post-operatively (localized CBCT) in order to assess the changes in the alveolar ridge dimensions. The next stage of the study refers to the rehabilitation of the edentulous region.
Before each patient was subjected to dental implant placement, a bone biopsy was obtained.
Therefore, all the biopsy specimens obtained went through histological evaluation in order to assess qualitative and quantitative features.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Athens, Greece, 11527
- Athens Univeristy Dental School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Single-rooted teeth needed to be extracted in the maxilla or mandible
- Patient in good general health as documented by self-assessment
- Patients must be committed to the study and sign the informed consent
- Adults only as participants
Exclusion Criteria:
- No systemic medical condition that could interfere with the surgical procedure or planned treatment.
- Smokers >20 cig/day
- Current pregnancy or breast feeding
- Radiotherapy or chemotherapy in head and neck area intravenous and oral bisphosphonates or anti-angiogenic drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 1: Control
In these post-extraction sockets no intervention takes place.
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Experimental: Group 2: Allograft and collagen membrane
In order to perform alveolar ridge preservation in this group allograft and collagen membrane are placed in the post-extraction sockets.
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The post-extraction sockets will be filled with allograft particles and collagen membrane.
Other Names:
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Experimental: Group 3: Allograft and L-PRF membrane
In order to perform alveolar ridge preservation in this group allograft and L-PRF membrane are placed in the post-extraction sockets.
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The post-extraction sockets will be filled with allograft particles and L-PRF membrane.
Other Names:
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Experimental: Group 4: L-PRF membrane
In order to perform alveolar ridge preservation in this group L-PRF membrane is placed in post-extraction sockets.
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The post-extraction sockets will be filled with L-PRF membrane.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic assessment of the bone specimens
Time Frame: 3 months
|
Comparison of quantitative clinical alveolar ridge dimensions (in mm) between the four groups will be performed, 3 months after alveolar ridge preservation.
Radiographic evaluation will take place and changes in horizontal dimension will be measured.
The horizontal bone width of the ridge at the time of the extraction and after 3 months during the implant placement procedure will be measured in mm.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic assessment of the bone specimens
Time Frame: 3 months
|
Comparison of quantitative clinical alveolar ridge dimensions (in mm) between the four groups will be performed, 3 months after alveolar ridge preservation.
Radiographic evaluation will take place and changes in vertical dimension will be measured.
The vertical bone height of the ridge at the time of the extraction and after 3 months during the implant placement procedure will be measured in mm.
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3 months
|
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Histological assessment of the bone harvested from the post-extraction sockets
Time Frame: 3 months
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Measure quantitative histologic characteristics of new bone formation between the four groups after 3 months of alveolar ridge preservation by quantifying the distribution in (%) of new vital bone formed at the healed socket site.
|
3 months
|
Collaborators and Investigators
Investigators
- Study Chair: Nadia Lygidakis, Associate Professor, National and Kapodistrian University of Athens
Publications and helpful links
General Publications
- Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.
- Temmerman A, Vandessel J, Castro A, Jacobs R, Teughels W, Pinto N, Quirynen M. The use of leucocyte and platelet-rich fibrin in socket management and ridge preservation: a split-mouth, randomized, controlled clinical trial. J Clin Periodontol. 2016 Nov;43(11):990-999. doi: 10.1111/jcpe.12612. Epub 2016 Sep 21.
- Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.
- Barone A, Ricci M, Tonelli P, Santini S, Covani U. Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing. Clin Oral Implants Res. 2013 Nov;24(11):1231-7. doi: 10.1111/j.1600-0501.2012.02535.x. Epub 2012 Jul 12.
- Dohan Ehrenfest DM, Pinto NR, Pereda A, Jimenez P, Corso MD, Kang BS, Nally M, Lanata N, Wang HL, Quirynen M. The impact of the centrifuge characteristics and centrifugation protocols on the cells, growth factors, and fibrin architecture of a leukocyte- and platelet-rich fibrin (L-PRF) clot and membrane. Platelets. 2018 Mar;29(2):171-184. doi: 10.1080/09537104.2017.1293812. Epub 2017 Apr 24.
- Choukroun, J., Adda, F., Schoeffler, C., &Vervelle, A. (2001). Une opportunit?? enparo-implantologie: Le PRF. Implantodontie, 42, 55-62.
- Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part B: sinus floor elevation, alveolar ridge preservation and implant therapy. A systematic review. J Clin Periodontol. 2017 Feb;44(2):225-234. doi: 10.1111/jcpe.12658. Epub 2017 Jan 10.
- Castro AB, Van Dessel J, Temmerman A, Jacobs R, Quirynen M. Effect of different platelet-rich fibrin matrices for ridge preservation in multiple tooth extractions: A split-mouth randomized controlled clinical trial. J Clin Periodontol. 2021 Jul;48(7):984-995. doi: 10.1111/jcpe.13463. Epub 2021 Apr 18.
- Cammack GV 2nd, Nevins M, Clem DS 3rd, Hatch JP, Mellonig JT. Histologic evaluation of mineralized and demineralized freeze-dried bone allograft for ridge and sinus augmentations. Int J Periodontics Restorative Dent. 2005 Jun;25(3):231-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 415/23.05.2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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