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

Not Applicable

Completed

• Conditions: Third Molar Extraction; Tooth Extraction; Oral Pain
• Interventions: Radiation: Low frequency laser activated photobiomodulation; Other: Low frequency laser photobiomodulation inactive

• Registration Number: NCT05255731
• Lead Sponsor: University of Santiago de Compostela

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 ).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-01
• Study Start: 2022-02-15
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-24
• Primary Completion: 2023-07-30
• Study Completion: 2023-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Group (GL)	Low frequency laser activated photobiomodulation	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.
Control Group (CG)	Low frequency laser photobiomodulation inactive	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.

Primary Outcome Measures

Name	Time	Method
Evaluate edema after surgery	7 days	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).

Secondary Outcome Measures

Name	Time	Method
Reported pain	7 days	The degree of pain reported by patients using a visual analogue scale (VAS). Scale from 0 to 10, where zero means no pain and ten means severe pain
Rescue medication for pain	7 days	To assess whether there has been a change in the amount of pills consumed as rescue medication for pain management. Through the number of pills used by the patient after each surgery.
Trismus	7 days	With a ruler the distance of the maximum opening between the upper right and lower right central incisors before surgery will be measured (the measurement in centimetres). The smaller the measurement of mouth opening obtained, compared to the initial measurement, the greater the post-operative trismus)

Trial Locations

Locations (1)

Universidad de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain