Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers

December 19, 2023 updated by: Universidad de los Andes, Chile

Platelet Rich Fibrin as a Modulator of the Wound Healing Response in Smokers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • This study will be conducted according to the principles outlined in the Declaration of Helsinki regarding experiments on human beings. This work was submitted and approved by the Ethics and Scientific Committee, approval number ID170706007.
  • Participant selection: Volunteers must agree to participate in the study after signing an informed consent (previously approved by the Ethics Committee). Participants will be treated at the Dental Clinical School of Dentistry at the Pontificia Universidad Católica de Chile or in the Dentistry/ Health Sciences Center at San Bernardo from the University of the Andes, Chile. Both institutions are located in Santiago, Chile.

Diagnosis and evaluation before interventions: Volunteer participants will be selected after a clinical and periapical radiographic examination to establish the need for tooth extraction. Laboratory tests, including a complete blood coagulation profile, will be required for all volunteers. Finally, a salivary cotinine test will ensure the smoker's condition.

  • Randomization: A random number will be assigned to all participants. An independent research team member will establish a randomization sequence without contact with the clinician's team. Sealed envelopes with randomization will be performed and opened by surgeons before the tooth extraction.
  • First Intervention: Participants assigned to the experimental group will be treated with L-PRF plugs and membranes from 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, and the control group will be sutured. Participants in both groups will be 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.
  • Second Intervention: 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.
  • The primary outcome variable established will be radiographic 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. Secondary outcomes included the changes in ridge contours and volume estimated from the intraoral scan images.
  • Data analysis: Members of the research team who do not know the group intervention of the participants will determine alveolar ridge height and width in oral scans and CBCTs taken in the first and second Interventions. As such, micro-CT analysis and histological sections will be analyzed.
  • Statistical analysis The results will express the mean ± 95% CI. Will be considered as significant differences when P < 0.05. Nominal data will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago de Chile, Region Metropolitana, Chile, 8051285
        • Recruiting
        • Dental facility, Health center at San Bernardo, Faculty of Dentistry, University of the Andes
        • Contact:
    • Región Metropolitana
      • Santiago de Chile, Región Metropolitana, Chile, 7820436
        • Enrolling by invitation
        • Clinical Facility, School of Dentistry, Pontificia Universidad Católica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control

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
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.
Experimental: L-PRF Treatment
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alveolar ridge changes
Time Frame: inmediately after tooth extraction and after four months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alveolar ridge sof tissue changes
Time Frame: inmediately after tooth extraction and after four months
changes in ridge contours and volume estimated from the intraoral scan images
inmediately after tooth extraction and after four months
Tissue healing
Time Frame: Biopsy at least four months after tooth extraction
Tissue analysis by Micro-CT and histological sections.
Biopsy at least four months after tooth extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de los Andes, Chile

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pontificia Universidad Catolica de Chile

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Constanza Martínez, DDS PhD, University of the Andes, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1181007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will underlie results in a publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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