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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 ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reported pain | 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 | 7 days |
| Rescue medication for pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Santiago de Compostela | Santiago de Compostela | A Coruña | 15785 | Spain |
The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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One side the laser off will be applied, on the other side, the laser on will be applied,
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| Low frequency laser photobiomodulation inactive | Other | The same protocol as the activated group |
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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.
| 7 days |
| Trismus | 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) | 7 days |