Laser Therapy, Low-LevelCSBENCT06943391

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

A study testing laser in people with Laser Therapy, Low-Level, run by Universidad de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Laser Therapy, Low-Level
What is being tested?: laser
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteSpain
Study dates: 20 Jun 2020to 20 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Lopez-Jornet Pia
Mur, Spain, 30008

Other trials in Spain

About this study

Official title: 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

Conditions: Laser Therapy, Low-Level
Being tested: laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

laserDevice
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.

Study groups in NCT06943391
Study group	Role	What they receive
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 Receives: Device: laser
Group Sham	Sham comparator	patients undergoing tooth extraction and the application of inactive/simulated PBM im-mediately after using the same procedure Receives: Device: laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Self-reported Pain Scores Using 0m Visual Analog Scale 10 Pain Score.Total pain improvement over day 0 to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202020 Jun 2024

First posted24 Apr 2025
Study start20 Jun 2020
Primary completion20 Jun 2024
Study completion20 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Laser Therapy, Low-LevelStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: Single blind
Who is masked: Participant
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06943391
Sponsor's protocol ID: ID: 2934/2020
Acronym: CSBE
Status last verified: Apr 2025
First submitted: 16 Apr 2025
Last updated: 24 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32802287
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.
PubMed 38821660

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Laser Therapy, Low-Level trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CLINICAL STUDY OF BIOSTIMULATION WITH LOW-POWER DIODE LASER AFTER DENTAL EXTRACTIONS
ClinicalTrials.gov ID: NCT06943391
Acronym / sponsor ID: CSBE / ID: 2934/2020
Conditions: Laser Therapy, Low-Level
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Universidad de MurciaUniversity, hospital or other
Study start: 20 Jun 2020 (actual)
Primary completion: 20 Jun 2024 (actual)
Study completion: 20 Jun 2024 (actual)
First posted: 24 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: 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

Arm	Type	Receives
Group I (Experimental):	Experimental	Device: laserpatients 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
Group Sham	Sham comparator	Device: laserpatients undergoing tooth extraction and the application of inactive/simulated PBM im-mediately after using the same procedure

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
laserpatients 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.	Device	Group I (Experimental):, Group Sham

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Background: PubMed 32802287Ahrari 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.
Background: PubMed 38821660Camolesi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing laser in people with Laser Therapy, Low-Level, run by Universidad de Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06943391, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.