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

University of Santiago de Compostela

Status: Completed

Conditions: Tooth Extraction; Third Molar Extraction; Oral Pain

Treatments: Radiation: Low frequency laser activated photobiomodulation; Other: Low frequency laser photobiomodulation inactive

Study type: Interventional

Funder types: Other

Identifiers

NCT05255731

RCT-PBM/TM-USC/UB-22

Details and patient eligibility

About

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 ).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Laser Group (GL)

Active Comparator group

Description:

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.

Treatment:

Radiation: Low frequency laser activated photobiomodulation

Control Group (CG)

Placebo Comparator group

Description:

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.

Treatment:

Other: Low frequency laser photobiomodulation inactive