Clinical Study of Biostimulation With Low-Power Diode Laser After Dental Extractions (CSBE)

April 16, 2025 updated by: Universidad de Murcia

CLINICAL STUDY OF BIOSTIMULATION WITH LOW-POWER DIODE LASER AFTER DENTAL EXTRACTIONS

the objective of the present work is to assess the efficacy of photobiomodulation (PBM) with respect to pain, inflammation, and healing after tooth extractions as compared with a sham treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • 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 Locations

  • Spain
      • Mur, Spain, 30008
        • Lopez-Jornet Pia

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria: adult patients who needed tooth extractions for any reason and who signed an informed consent form

Exclusion Criteria:patients who according to the ASA preoperative evaluation, did not meet the medical con-ditions for a surgical intervention. Immunocompromised patients. Patients with decom-pensated systemic diseases; undergoing chemotherapy treatment or taking immunosup-pressants. Pregnant women. Patients with severe mental disorders. Patients who had re-ceived head and neck radiotherapy

-

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (Experimental):
patients subjected to a tooth extraction and immediately given an intraoral PBM session with an EPIC X Biolase diode laser (BIOLASE, Inc. USA), . It was applied at three points in the area: buccal, pala-tal/lingual, and occlusal to stimulate the tissue
Device: laser
patients subjected to a tooth extraction and immediately given an intraoral PBM session with an EPIC X Biolase diode laser (BIOLASE, Inc. USA), with a voltage of 100-240 V, 1.5 A, a power of 0.5 W, and an application of an energy of 15J per cm², for 10-30 seconds at 1 mm of the tissue with an sterile surgical tip. It was applied at three points in the area: buccal, pala-tal/lingual, and occlusal to stimulate the tissue.
Sham Comparator: Group Sham
patients undergoing tooth extraction and the application of inactive/simulated PBM im-mediately after using the same procedure
Device: laser
patients subjected to a tooth extraction and immediately given an intraoral PBM session with an EPIC X Biolase diode laser (BIOLASE, Inc. USA), with a voltage of 100-240 V, 1.5 A, a power of 0.5 W, and an application of an energy of 15J per cm², for 10-30 seconds at 1 mm of the tissue with an sterile surgical tip. It was applied at three points in the area: buccal, pala-tal/lingual, and occlusal to stimulate the tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Self-Reported Visual Analog Scale - VAS, 0-10)
Time Frame: Self-reported Pain Scores Using 0m Visual Analog Scale 10 Pain Score.Total pain improvement over day 0 to day 7
hange in self-reported pain scores from Day 0 to Day 7 using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Self-reported Pain Scores Using 0m Visual Analog Scale 10 Pain Score.Total pain improvement over day 0 to day 7

Collaborators and Investigators

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

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 20, 2020

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

June 20, 2024

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ID: 2934/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Laser Therapy, Low-Level

Clinical Trials on laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe