Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers

NCT06190860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-01-05

No results posted yet for this study

Summary

Bone healing is affected by smoking, particularly healing of extraction sockets, showing deficiencies in vertical and horizontal bone dimensions compared to the healing of non-smokers. Several approaches have been made to stimulate.

Bone wound healing, including human autologous blood-derived fractions. One of these fractions is the leukocyte platelet-rich fibrin (L-PRF).

L-PRF has been evidenced as potentially beneficial in promoting bone defect filling in alveolar bone and socket preservation in non-smokers. However, scarce evidence is related to this beneficial effect in smokers.

This clinical trial aims to study and compare the in vivo effects of L-PRF during bone wound healing and regeneration in smokers.

The main question is:

Has the L-PRF a beneficial effect during alveolar ridge preservation in smokers? After consent, participants with tooth extraction indications and implant rehabilitation treatment will be enrolled. After randomization, participants will be assigned to an experimental group treated with L-PRF plugs and membranes or a control group (physiological healing).

Participants will receive two interventions:

* First intervention: Tooth extraction, intraoral scan, and Cone Beam Computed Tomography in the treated zone.
* Second intervention (4 months after first intervention): intraoral scan and Cone Beam Computed Tomography in the treated zone

Conditions

  • Alveolar Process Atrophy
  • Smoking, Cigarette
  • Platelet-Rich Fibrin

Interventions

OTHER

Autologous Leukocyte and platelet-rich fibrin

Participants will be treated with L-PRF plugs and membranes from autologous venous blood. Participants will have drawn blood after venipuncture (median cubital vein) into sterile, glass-coated plastic 9 mL tubes without anticoagulant. These tubes will be centrifuged at 2700 rpm for 12 min (Relative Centrifugal Forces-clot = 408 g). After tooth extraction, participants in the experimental group will be treated with L-PRF plugs and membranes.

OTHER

Intraoral Scan

Intraoral scan will be taken in the treated zone after tooth extraction and after four months.

RADIATION

Computed Tomography

Cone Beam Computed Tomography in the treated zone will be taken after tooth extraction and after four months.

OTHER

Biopsy

Before dental implant placement, a biopsy (2 mm in diameter) will be taken. The biopsy will be analyzed by Micro-computed tomography and decalcified and included in paraffin for histological sections.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER
  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Constanza Martínez, DDS PhD · University of the Andes, Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-29
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190860 on ClinicalTrials.gov