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

NCT ID: NCT05255731

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Laser Group (GL)

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.

Group Type: ACTIVE_COMPARATOR

Low frequency laser activated photobiomodulation

Intervention Type: 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.

Control Group (CG)

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.

Group Type: PLACEBO_COMPARATOR

Low frequency laser photobiomodulation inactive

Intervention Type: OTHER

The same protocol as the activated group

Interventions

Low frequency laser activated photobiomodulation

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.

Intervention Type: RADIATION

Low frequency laser photobiomodulation inactive

The same protocol as the activated group

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Mario Pérez Sayáns

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Other Identifiers

RCT-PBM/TM-USC/UB-22

Identifier Type: -

Identifier Source: org_study_id