Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial.

NCT05662709 | Unknown Phase 3

• 1 other identifier: 17/262-O_P
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clínical trial is to compare in patients needing extraction of anterior teeth the effects of leukocyte-and platelet-rich fibrin (L-PRF) for alveolar ridge preservation versus spontaneous healing. The main questions it aims to answer are:

• Does L-PRF use as alveolar ridge preservation material diminish volumetric changes in the alveolar ridge produced after tooth extraction and further bone regeneration needs?
• Does it have any advantage for wound healing and patient-related outcomes? Participants will undergo
• Tooth extraction
• Alveolar ridge preservation/ spontaneous healing
• Implant placement Researchers will compare alveolar ridge preservation with L-PRF with spontaneous healing to see if there is an effect on reducing ridge dimensional changes happening after tooth extraction.

Conditions

Alveolar Ridge Preservation; Dental Implants

Keywords

platelet-rich fibrin; bone regeneration; alveolar ridge preservation; tooth extraction

Outcome Measures

Primary Outcomes (1)

• Radiographic linear changes in horizontal width of the alveolar ridge

  Cuantitative variable. A validated method to superimpose the radiographs will be used (Ortiz-Vigón et al., 2018; Sanz-Martín et al., 2019).A digital imaging software (SMOP®, Swissmeda Ltd©, Zurich, Switzerland) is used to convert DICOM files into STL files. The images from Baseline and 4 months CBCTs were superimposed using common reference points. After a "fine fit" of the two surfaces, it will appear as a merged contour in axial, coronal, and sagittal views. The center of the alveolus will be determined mesiodistally in the occlusal view. Linear changes in width between 4 months and baseline will be determined by horizontal lines drawn perpendicular to the longitudinal axis in the center of the socket. Three measurements will be taken at 1mm (HRW1), 3mm (HRW3), and 5mm (HRW5) below the Bl bone crest. The change will be calculated by subtraction of the 4 months to Baseline distance in millimeters.

  From tooth extraction (Baseline) to four months healing (4m)

Secondary Outcomes (6)

• Radiographic linear changes height of the alveolar ridge

  From tooth extraction (Baseline) to four months healing (4m)

• Changes in ridge contour

  From tooth extraction (Baseline) to four months healing (4m)

• Volumetric changes

  From tooth extraction (Baseline) to four months healing (4m)

• Patient reported outcome measures

  At one week, one month and four months visit.

• Bone regeneration needs

  4 months after tooth extraction

Other Outcomes (7)

• Peri implant probing depth

  At implant placement, 6 months and 12 months after loading

• Peri-implant Plaque index

  At implant placement, 6 months and 12 months after loading

• Bleeding on probing

  At implant placement, 6 months and 12 months after loading

Study Arms (2)

L-PRF

EXPERIMENTAL

Test group, alveolar ridge preservation with L-PRF after tooth extraction.

Procedure: Tooth extraction; Procedure: Alveolar ridge preservation with L-PRF

Spontaneous Healing (SH)

NO INTERVENTION

Control group, spontaneous healing of the socket after tooth extraction

Interventions

Tooth extraction PROCEDURE

Tooth extraction in the most atraumatic way

L-PRF

Alveolar ridge preservation with L-PRF PROCEDURE

Blood will be drawn from the patient, centrifugued and leukocyte and platelet-rich fibrin (L-PRF) will be obtained. L-PRF plugs and membranes will be prepared and placed in the socket after extraction

L-PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients ≥18 years old
• Need for extraction of a tooth in the anterior area (position of second premolar to second premolar in maxilla or mandible) that needs to be replaced by an implant-supported restoration
• Presence of natural teeth mesially and distally of tooth to be extracted, periodontally healthy (probing depths \<5 mm without bleeding on probing).

You may not qualify if:

• Systemic conditions affecting bone or soft tissue healing
• Smokers of more than 10 cigarettes a day or equivalent to cigarettes
• Breastfeeding or pregnant women
• Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, 28040, Spain

Location

Related Publications (13)

• Choukroun, J., Adda, F., Schoeffler, C., & Vervelle, A. (2001). The opportunity in perio-implantology: The PRF. Implantodontie, 42, 55-62.

  BACKGROUND

• Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.

  PMID: 19089687 BACKGROUND

• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.

  PMID: 22211303 BACKGROUND

• Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.

  PMID: 18672985 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

• Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23.

  PMID: 30246362 BACKGROUND

• 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.

  PMID: 22211304 BACKGROUND

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 BACKGROUND

• Ortiz-Vigon A, Suarez I, Martinez-Villa S, Sanz-Martin I, Bollain J, Sanz M. Safety and performance of a novel collagenated xenogeneic bone block for lateral alveolar crest augmentation for staged implant placement. Clin Oral Implants Res. 2018 Jan;29(1):36-45. doi: 10.1111/clr.13036. Epub 2017 Jul 14.

  PMID: 28710793 BACKGROUND

• Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06.005. Epub 2016 Jun 20.

  PMID: 27338946 RESULT

• 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.

  PMID: 27509214 RESULT

• Thalmair T, Fickl S, Schneider D, Hinze M, Wachtel H. Dimensional alterations of extraction sites after different alveolar ridge preservation techniques - a volumetric study. J Clin Periodontol. 2013 Jul;40(7):721-7. doi: 10.1111/jcpe.12111. Epub 2013 May 5.

  PMID: 23647007 RESULT

• Suttapreyasri S, Leepong N. Influence of platelet-rich fibrin on alveolar ridge preservation. J Craniofac Surg. 2013 Jul;24(4):1088-94. doi: 10.1097/SCS.0b013e31828b6dc3.

  PMID: 23851746 RESULT

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor blinded for treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, Master in Periodontology and Implant dentistry.

Model Details: Controlled clinical trial, 2 groups of patients undergoing tooth extraction, allocated to: * Test group: alveolar ridge preservation with L-PRF * Control group: spontaneous healing of the socket

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: April 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: May 30, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

ES (1)