Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

February 24, 2025 updated by: Fundación Eduardo Anitua

Randomized Clinical Trial, Controlled by Conventional Treatment, of Plasma Rich in Growth Factors (PRGF®) in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
44

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.
  • Phase 3

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

  • Spain
      • Vitoria, Spain
        • Clinica Eduardo Anitua

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age> 18 years
  • Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars)
  • Need to place a dental implant in the same position of the extraction
  • Availability of observation during the period of treatment
  • Signature of the informed consent

Exclusion Criteria:

  • Third molars
  • Active periodontal disease
  • Simultaneous extraction of two adjacent pieces in the same quadrant
  • Oral dehiscence ≥ 25%
  • Alveolus depth <7mm
  • Loss of some wall of the alveolus
  • Severe inflammation in the extraction area
  • Previous diagnosis of coagulopathies
  • Previous diagnosis of autoimmune disease
  • Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants
  • Regular treatment with NSAIDs
  • History of chronic hepatitis or liver cirrhosis
  • Positive markers for HCV, AfHBs, HIV-I / II or TP
  • Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin> 9%)
  • Dialysis treatment
  • Presence of malignant tumors, hemangiomas or angioma in the extraction area.
  • History of ischemic heart disease in the last year
  • Pregnancy or women of childbearing age who do not take action contraceptives
  • Lactating women
  • Previous diagnosis of metabolic bone disease
  • Antiresorptive treatment
  • Treatment with monoclonal antibodies
  • Smoker> 10 cigarettes / day
  • Any inability to participate in the study

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: Single

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.
Active Comparator: Simple suture
Atraumatic exodontia followed by simple suture
Drug: Blood clot and simple suture
Filling the alveolus with blood clot
Experimental: PRGF-Endoret
Atraumatic exodontia followed by simple suture
Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)
Filling of the alveolus with PRGF clot and fibrin plug.

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
Bone regeneration
Time Frame: 12 weeks post-extraction
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
12 weeks post-extraction

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
Visual Analogue Score (VAS)
Time Frame: 3, 7 and 15 days post-extraction
Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)
3, 7 and 15 days post-extraction
Inflammation score
Time Frame: 3, 7 and 15 days post-extraction
Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation)
3, 7 and 15 days post-extraction
Soft tissue healing index
Time Frame: 3, 7 and 15 days post-extraction
Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing)
3, 7 and 15 days post-extraction
Changes in the dimension of the alveolar ridge
Time Frame: 12 weeks post-extraction
Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction
12 weeks post-extraction
Soft tissue histomorphometric changes
Time Frame: 12 weeks post-extraction
- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy
12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge
Time Frame: 12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction.
12 weeks post-extraction
Change in bone density
Time Frame: 12 weeks post-extraction
Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks.
12 weeks post-extraction
Vitamin D levels
Time Frame: 12 weeks post-extraction
12 weeks post-extraction
Frequency of surgical and postsurgical complications
Time Frame: 12 weeks post-extraction
12 weeks post-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.
Fundación Eduardo Anitua

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.
September 2, 2020

Primary Completion (Actual)

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.
January 31, 2025

Study Completion (Actual)

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.
January 31, 2025

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).
June 15, 2021

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.
June 22, 2021

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.
June 30, 2021

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.
March 25, 2025

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.
February 24, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

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.
  • BTIIMD_01_EC/20/Molares

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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