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

NCT06943391 | Completed DMC

• 1 other identifier: ID: 2934/2020
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laser Therapy, Low-Level

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (Self-Reported Visual Analog Scale - VAS, 0-10)

  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

Study Arms (2)

Group I (Experimental):

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

Group Sham

SHAM COMPARATOR

patients undergoing tooth extraction and the application of inactive/simulated PBM im-mediately after using the same procedure

Device: laser

Interventions

laser DEVICE

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.

Group I (Experimental):; Group Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Lopez-Jornet Pia

Mur, Spain, 30008, Spain

Location

Related Publications (2)

• Ahrari F, Eshghpour M, Zare R, Ebrahimi S, Fallahrastegar A, Khaki H. Effectiveness of Low-Level Laser Irradiation in Reducing Pain and Accelerating Socket Healing After Undisturbed Tooth Extraction. J Lasers Med Sci. 2020 Summer;11(3):274-279. doi: 10.34172/jlms.2020.46. Epub 2020 Jun 21.

  PMID: 32802287 BACKGROUND

• Camolesi GCV, Silva FFVE, Aulestia-Viera PV, Marichalar-Mendia X, Gandara-Vila P, Perez-Sayans M. IS THE PHOTOBIOMODULATION THERAPY EFFECTIVE IN CONTROLLING POST-SURGICAL SIDE EFFECTS AFTER THE EXTRACTION OF MANDIBULAR THIRD MOLARS? A SYSTEMATIC REVIEW AND META-ANALYSIS. J Evid Based Dent Pract. 2024 Jun;24(2):101983. doi: 10.1016/j.jebdp.2024.101983. Epub 2024 Feb 28.

  PMID: 38821660 BACKGROUND

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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), 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, based on the opti-mum biostimulation parameters by Cronshaw et al. . It was applied at three points in the area: buccal, palatal/lingual, and occlusal to stimulate the tissue. Group II (Sham): pa-tients undergoing tooth extraction and the application of inactive/simulated PBM imme-diately after using the same procedure

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: June 20, 2020
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

ES (1)