NCT02300246

Brief Summary

The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with biomechanical processing simplified and without the need for handling blood biochemistry. Some studies have shown the potential of PRF in release growth factors assisting and accelerating the regeneration of soft tissues, however with contradictory results regarding the hard tissues. The aim of this study will be to evaluate through clinical analyzes, histomorphometric and micro-computed tomographic images, the dimensional changes, the quantity and the quality of the tissues formed socket after extractions that receive membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and the other 15 (control group) received no biomaterial (spontaneous healing).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

November 20, 2014

Last Update Submit

November 21, 2014

Conditions

Alveolar Socket Preservation

Keywords

alveolar socket preservationtooth extractionplatelet concentratesgrowth factors

Outcome Measures

Primary Outcomes (1)

  • Dimensional changes of the alveolar crest.

    Clinical examination, histological and micro-computed tomography analyses will be conducted.

    120 days

Study Arms (2)

Test Group

EXPERIMENTAL

Alveolar socket post-extraction covered with PRF

Procedure: Platelet-Rich Fibrin

Control Group

NO INTERVENTION

Only clot (spontaneous healing)

Interventions

Platelet-Rich FibrinPROCEDURE

Alveolar socket preservation with Platelet-Rich Plasma

Test Group

Eligibility Criteria

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

You may qualify if:

  • Patients aged over 18 years
  • Healthy patients with indication for dental extraction
  • Teeth adjacent to the extraction site
  • Patients willing to cooperate with the study and who have signed the informed consent form.

You may not qualify if:

  • Patients showing periapical or periodontal infection
  • Patients with severe systemic diseases
  • Patients on medications such as chemotherapy, anticoagulants, corticosteroids, biphosphonates and drugs imunossupressivas
  • Patients who have chronic diseases decompensated (e.g. hypertension, diabetes, rheumatic diseases, renal, and hepatic)
  • Patients with bone diseases, metabolic (osteomalacia, hypocalcemia and hypercalcemia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vittorio Moraschini

Niterói, Rio de Janeiro, 24230126, Brazil

RECRUITING

Related Publications (4)

  • Farina R, Bressan E, Taut A, Cucchi A, Trombelli L. Plasma rich in growth factors in human extraction sockets: a radiographic and histomorphometric study on early bone deposition. Clin Oral Implants Res. 2013 Dec;24(12):1360-8. doi: 10.1111/clr.12033. Epub 2012 Sep 24.

    PMID: 22998461BACKGROUND

  • 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: 23851746BACKGROUND

  • Alissa R, Esposito M, Horner K, Oliver R. The influence of platelet-rich plasma on the healing of extraction sockets: an explorative randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):121-34.

    PMID: 20623037BACKGROUND

  • Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.

    PMID: 23644909RESULT

Central Study Contacts

Vittorio Moraschini, PhD

CONTACT

55(21)996626930vittoriomf@terra.com.br

Eliane Barboza, PhD

CONTACT

55(21)979808811elianeporto.uff@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

BR(1)