NCT07387913

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2022Sep 2026

Study Start

First participant enrolled

September 5, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Expected
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

January 18, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

Dental implantPlatelet-rich fibrinAlveolar ridge preservationDental implant stabilityTooth-socket preservation

Outcome Measures

Primary Outcomes (1)

  • Radiographic assessment of the bone specimens

    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.

    3 months

Secondary Outcomes (2)

  • Radiographic assessment of the bone specimens

    3 months

  • Histological assessment of the bone harvested from the post-extraction sockets

    3 months

Study Arms (4)

Group 1: Control

NO INTERVENTION

In these post-extraction sockets no intervention takes place.

Group 2: Allograft and collagen membrane

EXPERIMENTAL

In order to perform alveolar ridge preservation in this group allograft and collagen membrane are placed in the post-extraction sockets.

Procedure: Allograft and collagen membrane

Group 3: Allograft and L-PRF membrane

EXPERIMENTAL

In order to perform alveolar ridge preservation in this group allograft and L-PRF membrane are placed in the post-extraction sockets.

Procedure: Allograft and L-PRF membrane

Group 4: L-PRF membrane

EXPERIMENTAL

In order to perform alveolar ridge preservation in this group L-PRF membrane is placed in post-extraction sockets.

Procedure: L-PRF

Interventions

The post-extraction sockets will be filled with allograft particles and L-PRF membrane.

Also known as: Group 3
Group 3: Allograft and L-PRF membrane
L-PRFPROCEDURE

The post-extraction sockets will be filled with L-PRF membrane.

Also known as: Group 4
Group 4: L-PRF membrane

The post-extraction sockets will be filled with allograft particles and collagen membrane.

Also known as: Group 2
Group 2: Allograft and collagen membrane

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athens Univeristy Dental School

Athens, 11527, Greece

Location

Related Publications (9)

  • Choukroun, J., Adda, F., Schoeffler, C., &Vervelle, A. (2001). Une opportunit?? enparo-implantologie: Le PRF. Implantodontie, 42, 55-62.

    BACKGROUND
  • 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.

    PMID: 27891638BACKGROUND
  • 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.

    PMID: 33847018BACKGROUND
  • 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.

    PMID: 28551729BACKGROUND
  • 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: 27509214BACKGROUND
  • 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: 22211304BACKGROUND
  • 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.

    PMID: 22784417BACKGROUND
  • 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.

    PMID: 28437133BACKGROUND
  • 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.

    PMID: 16001735BACKGROUND

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Nadia Lygidakis, Associate Professor

    National and Kapodistrian University of Athens

    STUDY CHAIR

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
BDS(Hons), MSc, PhD candidate, Oral and Maxillofacial University Clinic, Athens Dental School

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 4, 2026

Study Start

September 5, 2022

Primary Completion

May 20, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations