Effect of Low Power Laser in the Pain After Lower Tooth Extraction

NCT05255731 | Completed

• 1 other identifier: RCT-PBM/TM-USC/UB-22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort during the first postoperative days. These complications arise from an inflammatory response, which is a direct and immediate consequence of the surgical intervention and can limit the patients' daily functions in the recovery phase and compromise their quality of life. Several methods have been used to control postoperative morbidity related to wisdom tooth extraction, including administration of proteolytic enzymes, tube drains, cryotherapy, anti-inflammatory and analgesic drugs and low level laser therapy. Objectives: To test whether the use of low power laser can improve post-operative pain, swelling and healing of the surgical wound. Material and methods: A double-centre, randomised, split-mouth, double-centre clinical study will be carried out in 38 patients per centre, totalling 76 patients and 152 wisdom teeth, who will undergo surgery for the extraction of the lower third molars. The necessary data for the study will be taken on the days of the consultation for surgery planning, on the day of surgery, by the patient on each post-operative day and on the 7th post-operative day (at the time of suture removal ).

Conditions

Third Molar Extraction; Oral Pain; Tooth Extraction

Keywords

Dentistry; Tooth extraction; Photobiomodulation; Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate edema after surgery

  To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra and extra-orally on the post-operative edema (by measuring in centimetres obtained by a ruler - external contour of the face from the tragus to the labial comisure, from the gonion to the external ocular corner, the greater the measurement obtained, when compared with the initial measurement, the greater the post-operative edema).

  7 days

Secondary Outcomes (3)

• Reported pain

  7 days

• Rescue medication for pain

  7 days

• Trismus

  7 days

Study Arms (2)

Laser Group (GL)

ACTIVE COMPARATOR

Patients will be submitted to a low power laser application immediately after suturing of the surgical area. The radiation emission shall be conducted according to protocol.

Radiation: Low frequency laser activated photobiomodulation

Control Group (CG)

PLACEBO COMPARATOR

In these patients the investigators will use the same protocol applied in the experimental group (time and application values) but the laser device will be turn off.

Other: Low frequency laser photobiomodulation inactive

Interventions

Low frequency laser activated photobiomodulation RADIATION

Protocol description Infrared: analgesia, biostimulation of tissues, edema and hyperemia (hard and soft tissues). There will be 11 laser application points, 3 intra-oral and 8 extra-oral, with a total dose of 33J. Intraoral: one point in the region of the mandibular lingula (point of submersion of the mandibular nerve), one vestibular point and one lingual point in relation to the alveolus of the extracted wisdom tooth. Extraoral: for muscle relaxation, five points on the masseter muscle; for oedema drainage, one point in each lymph node region: parotid, submandibular and buccal.

Laser Group (GL)

Low frequency laser photobiomodulation inactive OTHER

The same protocol as the activated group

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require extraction of the two lower wisdom teeth due to previous infection or pain, orthodontics or crowding, caries and who have a similar degree of difficulty according to the Pell and Gregory/Winter classifications.
• Patients must have the capacity to understand and decide at the time of voluntarily signing the informed consent before any intervention related to the study is performed.
• Patients who, after being informed about the aims and procedures of the research, agree and sign the informed consent form. Patients must be willing and able to adhere to the study in order to complete the necessary visits.

You may not qualify if:

• Patients with uncontrolled systemic disease (ASA ≥ III).
• Patients with severe periodontal disease or acute pericoronitis.
• Smokers of more than 5 cigarettes per day.
• Pregnant and lactating women, as the effect of laser therapy in this population has not been studied, its use is contraindicated.

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One side the laser off will be applied, on the other side, the laser on will be applied,
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 24, 2022
• Study Start: February 15, 2022
• Primary Completion: July 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

ES (1)