Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative Edema baseline
研究概览
简要总结
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars.The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen)These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
详细描述
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. To control these events, the prophylactic use of anti-inflammatory steroids has been widely recommended by some authors. However, there is no strong evidence on the real benefits of its use as opposed to its possible side effects. Photobiomodulation has proven to be a good alternative when applied in the postoperative period to control pain, edema and lockjaw. On the contrary, its application prior to a procedure of this type has not been sufficiently evaluated. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars. Healthy individuals (ASA I), who have an indication for extraction and are included in the study, will be randomly divided into two groups: Control Group: with the administration of prophylactic Corticosteroid (Dexamethasone 8 mg/ 1h before surgery), and the simulated application of Photobiomodulation, under the same protocol as the Study Group and Study Group: to which Photobiomodulation will be applied by means of intraoral Low Intensity Laser with wavelengths of 660nm and 808nm applied at 4 anatomical points (power of 0.1W, radiant exposure of 1,061 J/cm2 and energy of 3J per point and an application time of 30 seconds, totaling 12J of energy). Besides, the extraoral application will be carried out with a cluster device of combined LEDs with a total exposure area of 20cm2, which will be composed of 5 LEDs with a wavelength of 630nm (power of 0.25W per LED, a radiant exposure of 3 J /cm2 and energy of 12 J per LED spot, with an exposure time of 48 seconds) and 4 LEDs with a wavelength of 850 nm (power of 0.3W per LED, a radiant exposure of 2.4 J/cm2 and an energy of 12J per LED point, and an exposure time of 40 seconds). The Study Group will be administered a placebo tablet simulating Dexamethasone, also 1 h before the surgical procedure. The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen) after the first 3 postoperative days, where Ketorolac 10 mg will be administered orally, in a regulated manner. These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Keywords: photobiomodulation, corticosteroids, extraction, edema, pain, lockjaw, quality of life, randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who present retained lower third molars, according to the degree of surgical difficulty of the procedure and the anatomical position.The selected molars will be those classified according to classes II and III and/or B or C of Pell and Gregory Classification; in vertical or mesio-angular position, according to the Winter Classification or Class II with need for ostectomy or III, with need for ostectomy and odontosection of the Prant Scale, modified by Amarillas-Escobar et al.
- •That have an indication for the extraction of the lower third molars (due to recurrent infections, bad anatomical position, orthodontic indication) or a professional indication presented in writing and that are healthy (ASA I, with a negative medical history).
- •Male or female gender.
- •Age between 18 and 50 years.
- •Good oral hygiene.
- •That they agree to participate in the study, after reading and signing the Informed Consent for participation in clinical research.
排除标准
- •Carriers of local alterations that contraindicate surgical intervention or complicate the postoperative period (example: acute phase pericoronitis in the last 30 days, ankylosis of the temporomandibular joint).
- •Presenting absence of upper and lower central incisors,
- •With a medical history of photosensitivity
- •During pregnancy or lactation,
- •That they were using anti-inflammatories or analgesics,
- •Allergic to any of the drugs used in the research (amoxicillin, ketorolac, acetaminophen, dexamethasone, chlorhexidine 2%, local anesthetics, sodium bisulfite, etc.)
- •That during surgery they present any type of complication (bleeding, transoperative difficulties, etc.), because these cases are not included within the expected pattern behavior for this type of surgery (these cases will be reported),
- •Surgical time greater than 90 minutes.
研究组 & 干预措施
Experimental Group
Experimental group (n=30 surgeries) - the participants will receive the FBM, 1 hour before the surgical procedure, plus a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).).
干预措施: Photobiomodulation (Device)
Experimental Group
Experimental group (n=30 surgeries) - the participants will receive the FBM, 1 hour before the surgical procedure, plus a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).).
干预措施: Placebo Corticosteroid (Drug)
Control Group
Control group (n=30 surgeries) - patients will receive conventional treatment with Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019), plus simulation of FBM application. The Laser device will be disconnected and will be applied to the same points as in the experimental group, in the immediate pre-operative period (Baseline).
干预措施: Simulation Photobiomodulation (Device)
Control Group
Control group (n=30 surgeries) - patients will receive conventional treatment with Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019), plus simulation of FBM application. The Laser device will be disconnected and will be applied to the same points as in the experimental group, in the immediate pre-operative period (Baseline).
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Postoperative Edema baseline
时间窗: Edema wil be evaluated immediatly before the surgery (baseline)
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points
Postoperative Edema - 48 hours postoperative
时间窗: Edema wil be evaluated at 2 postoperative days.
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Postoperative Edema - 7day postoperative
时间窗: Edema wil be evaluated at 7 postoperative days.
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
次要结局
- Postoperative Pain baseline(In this study, the VAS will be used immediately before surgery (Baseline))
- Postoperative Pain - 48 hours(In this study, the VAS will be used at 2 postoperative days)
- Postoperative Pain - 7 days(In this study, the VAS will be used 7 days before surgery)
- Postoperative use of analgesics - baseline(The amount of analgesics will be recorded in the baseline.)
- Postoperative use of analgesics - 7th days(The amount of analgesics will be recorded after the third postoperative day until the 7th. post-operative day.)
- Postoperative Trismus - baseline(In the present study, the previously calibrated evaluators will measure the mouth opening in each patient before the surgeries (baseline))
- Postoperative Trismus 48 hours(In the present study, the previously calibrated evaluators will measure the mouth opening in each patient at 2 postoperative days.)
- Postoperative Trismus - 7 days(In the present study, the previously calibrated evaluators will measure the mouth opening in each patient after 7 postoperative days.)
- Postoperative Local temperature baseline(baseline)
- Postoperative Local temperature 48 hours(Thermographic photographs wil be taken 2 days after surgery.)
- Postoperative Quality of life - 48 hours(Quality of life will be evaluated two days after surgery,)
- Postoperative Dysphagia 48 hours(Dysphagia will be evaluated at 2 days post-surgery)
- Postoperative Hematoma/ecchymosis - baseline(Hematoma/ecchymosis will be evaluated at baseline)
- Postoperative Local temperature - 7 days(Thermographic photographs wil be taken 7 days after surgery.)
- Postoperative Quality of life - baseline(Quality of life will be evaluated in the baseline)
- Postoperative Quality of life - 7 days(Quality of life will be evaluated seven days after surgery,)
- Postoperative Dysphagia baseline(Dysphagia will be evaluated at baseline)
- Postoperative Dysphagia - 7 days(Dysphagia will be evaluated 7 days post-surgery)
- Postoperative Hematoma/ecchymosis(Hematoma/ecchymosis will be evaluated 2 days after surgery,)
- Postoperative Hematoma/ecchymosis - 7 days(Hematoma/ecchymosis will be evaluated 7 days after surgery,)
研究者
Anna Carolina Ratto Tempestini Horliana
Clinical colaborator
University of Nove de Julho