Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers

NCT06190860 | Unknown

• 1 other identifier: 1181007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge changes

  linear changes in horizontal width and vertical height of the alveolar ridge measured in the CBCTs taken immediately after tooth extraction and after four months.

  inmediately after tooth extraction and after four months

Secondary Outcomes (2)

• Alveolar ridge sof tissue changes

  inmediately after tooth extraction and after four months

• Tissue healing

  Biopsy at least four months after tooth extraction

Study Arms (2)

Control

OTHER

Post-extraction sockets will be sutured and left to heal spontaneously with physiological blood clot. First intervention: intraoral scan and intraoral scan and Cone Beam Computed Tomography in the treated zone. Clinicians will make a post-surgical control to evaluate how healing will be performed Four months after the first Intervention, participants will recall getting a second scan and Cone Beam Computed Tomography in the treated zone. Images will be used for implant treatment planification. Before 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.

Other: Intraoral Scan; Radiation: Computed Tomography; Other: Biopsy

L-PRF Treatment

EXPERIMENTAL

Post-extraction sockets will be treated with L-PRF plugs and membranes. First intervention: intraoral scan and intraoral scan and Cone Beam Computed Tomography in the treated zone. Clinicians will make a post-surgical control to evaluate how healing will be performed Four months after the first Intervention, participants will recall getting a second scan and Cone Beam Computed Tomography in the treated zone. Images will be used for implant treatment planification. Before 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.

Other: Autologous Leukocyte and platelet-rich fibrin; Other: Intraoral Scan; Radiation: Computed Tomography; Other: Biopsy

Interventions

Autologous Leukocyte and platelet-rich fibrin OTHER

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.

L-PRF Treatment

Intraoral Scan OTHER

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

Control; L-PRF Treatment

Computed Tomography RADIATION

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

Control; L-PRF Treatment

Biopsy OTHER

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.

Control; L-PRF Treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers (at least five cigarettes/day) have had the habit for at least one year.
• treatment plan that includes the indication of extraction of a single, double-rooted, or multi-rooted tooth and prosthetic rehabilitation with osseointegrated implants
• Patients with controlled systemic pathologies (hypertension, diabetes, hypercholesterolemia).
• With alveolar bone support of at least 50% and whose indication is delayed implant placement at least four months after extraction.
• Periapical lesions of no more than 5 mm diameter.

You may not qualify if:

• patients taking immunosuppressive or anticoagulant drugs
• pregnant
• users of removable prostheses
• Individuals with altered values of platelet count or coagulation parameters.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Pontificia Universidad Catolica de Chile: collaborator

Study Sites (2)

Clinical Facility, School of Dentistry, Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 7820436, Chile

ENROLLING BY INVITATION

Dental facility, Health center at San Bernardo, Faculty of Dentistry, University of the Andes

Santiago, Santiago Metropolitan, 8051285, Chile

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss; Cigarette Smoking

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Constanza Martínez, DDS PhD

  University of the Andes, Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constanza Martínez, DDS PhD

CONTACT

56987660640; cemartinezc@uandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: May 29, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CL (2)