- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02657174
Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery
2016. január 12. frissítette: Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
Effectiveness of Low Level Laser at the Auriculotherapy Points, in Reducing Postoperative Pain in Third Molar Surgery
The association between low level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated or to reduce the quantity of these postoperative medications.
The objective of this study is to evaluate the efficiency of low level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery.
Eighty third molars surgeries will be performed in 40 healthy patients by a split-mouth design.
Immediately after surgery, each side of the patient's mouth will be randomly treated with different regimens in a double-blind design: low level laser in auricular acupuncture points or simulation of its use.
This treatment will be performed at 24 and 48 hours after surgery.
The primary variable is the post-operative pain.
The secondary variables are trismus, edema and local temperature.
They will be assessed at baseline, 24 hours, 48 hours and seven days after surgery.The blood samples for analysis of systemic inflammatory cytokines (TNF-α, interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours after surgery.
A tanulmány áttekintése
Állapot
Ismeretlen
Körülmények
Részletes leírás
Third molar surgery is the most common surgical procedure in dentistry.
A comfortable, fast postoperative return to daily activities has increased the need to control inflammation and its signs and symptoms, such as pain and edema.
Anti-inflammatories and analgesics have been used for this purpose, but they are not exempt from adverse effects, such as allergies and chronic gastritis, not to mention the medicine costs.
The association between low level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated or to reduce the quantity of these postoperative medications.
Among the advantages, we can mention the low risk of side effects, low cost and simplicity of application.
The objective of this study is to evaluate the efficiency of low level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery.
Eighty bilateral, symmetrical lower third molars surgeries will be performed in 40 healthy patients.
Each patient will be his or her own control, through a split-mouth technique.
Immediately after surgery, each side of the patient's mouth will be randomly treated with different regimens in a double-blind design: low level laser in auricular acupuncture points or simulation of its use (contralateral side).
This regimen will be repeated at 24 and 48 hours after surgery.
All patients will receive the same medication (paracetamol) and will be oriented to take it only if they have pain.
Neither the surgeon nor the patients know the assigned treatment.
The primary variable is the post-operative pain assessed by visual analog scale, and the secondary variables are trismus, edema, local temperature.
Dysphagia and presence of infection (systemic temperature, lymphadenopathy) will also be evaluated.
These variables will be assessed at baseline, 24 hours, 48 hours and seven days after surgery.
All adverse effects will be recorded.
The blood samples for analysis of systemic inflammatory cytokines (TNF-α, interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours after surgery.
Tanulmány típusa
Beavatkozó
Beiratkozás (Várható)
80
Fázis
- 4. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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São Paulo, Brazília, 01504-001
- Toborzás
- Nove de Julho University (Uninove)
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Kapcsolatba lépni:
- Anna Carolina RT Horliana, PhD
- Telefonszám: +5511 3385-9197
- E-mail: annacrth@gmail.com
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- healthy patients (negative medical history)
- teeth in position II B according classification of Pell and Gregory
- third molar with extraction indication (recurrent infections, poor position, orthodontic indication) with professional statement in writing.
Exclusion Criteria:
- allergic to any drug used in the research (e.g.paracetamol)
- pregnant or breastfeeding women
- smokers
- patients submitted to radiotherapy in the head and neck, systemic or local infection (e.g., pericoronitis or periodontal abscess)
- patients with injuries or radiolucent images associated with the third molar
- patients who have used anti-inflammatory drugs in the last three months
- drug users
- patients who present any complications during surgery (e.g., bleeding, surgical difficulty, surgery longer than 90 minutes).
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: G1- experimental active comparator group
G1 - (Experimental) 40 third molars surgeries will be performed in a conventional manner.
At the end of surgery low level laser in auricular acupuncture points will be applied for prevention of inflammation and pain in a split-mouth design.
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40 third molars surgeries will be performed in a conventional manner.
At the end of surgery, low level laser will be applied at auricular points for prevention of inflammation and pain in the immediate post-operative period (baseline).The operator will mark the points that will be irradiated on the outer atrium of the patient with red gel pen to avoid interference with red laser (λ = 660 nm).
The low level laser points will be irradiated in the same operated side.
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Placebo Comparator: G2- control group
G2 - (Control) 40 third molars surgeries will be performed in the conventional manner, identically to the G1.
At the end of surgery low level laser device off in auricular acupuncture points will be applied.
The patient will receive low level laser with a protection of lead in the laser nozzle, in order to block the passage of light, in the same auricular points used in G1, with split-mouth design.
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40 surgeries will be performed in the conventional manner, identically to the G1.
The patient will receive low level laser with a protection of lead in the laser nozzle, in order to block the passage of light, in the same auricular points used in G1.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Change in of post-operative pain by applying a visual analog scale
Időkeret: baseline
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The pain will be assessed by applying a visual analog scale, consisting of a 100-mm line numbered in centimeters, with two closed ends.
One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively.
Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation.
Instructions on marking will always be given to the patient by the same operator.
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baseline
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Change in of post-operative pain by applying a visual analog scale
Időkeret: Postoperative period: 24 hours after surgery
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The pain will be assessed by applying a visual analog scale, consisting of a 100-mm line numbered in centimeters, with two closed ends.
One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively.
Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation.
Instructions on marking will always be given to the patient by the same operator.
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Postoperative period: 24 hours after surgery
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Change in of post-operative pain by applying a visual analog scale
Időkeret: Postoperative period: 48 hours after surgery
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The pain will be assessed by applying a visual analog scale, consisting of a 100-mm line numbered in centimeters, with two closed ends.
One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively.
Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation.
Instructions on marking will always be given to the patient by the same operator.
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Postoperative period: 48 hours after surgery
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Change in of post-operative pain by applying a visual analog scale
Időkeret: Postoperative period: 7 days after surgery
|
The pain will be assessed by applying a visual analog scale, consisting of a 100-mm line numbered in centimeters, with two closed ends.
One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively.
Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation.
Instructions on marking will always be given to the patient by the same operator.
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Postoperative period: 7 days after surgery
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Changes in edema
Időkeret: baseline
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The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.
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baseline
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Changes in mouth opening assessed by the inter-incisor measurement
Időkeret: baseline
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For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper.
During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.
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baseline
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Changes in local temperature
Időkeret: baseline
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The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).
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baseline
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Changes in edema
Időkeret: Postoperative period: 24 hours after surgery
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The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.
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Postoperative period: 24 hours after surgery
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Changes in mouth opening assessed by the inter-incisor measurement
Időkeret: Postoperative period: 24 hours after surgery
|
For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper.
During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.
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Postoperative period: 24 hours after surgery
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Changes in local temperature
Időkeret: Postoperative period: 24 hours after surgery
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The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).
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Postoperative period: 24 hours after surgery
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Changes in edema
Időkeret: Postoperative period: 48 hours after surgery
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The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.
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Postoperative period: 48 hours after surgery
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Changes in mouth opening assessed by the inter-incisor measurement
Időkeret: Postoperative period: 48 hours after surgery
|
For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper.
During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.
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Postoperative period: 48 hours after surgery
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Changes in local temperature
Időkeret: Postoperative period: 48 hours after surgery
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The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).
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Postoperative period: 48 hours after surgery
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Changes in edema
Időkeret: Postoperative period: 7 days after surgery
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The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.
|
Postoperative period: 7 days after surgery
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Changes in mouth opening assessed by the inter-incisor measurement
Időkeret: Postoperative period: 7 days after surgery
|
For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper.
During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.
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Postoperative period: 7 days after surgery
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Changes in local temperature
Időkeret: Postoperative period: 7 days after surgery
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The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).
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Postoperative period: 7 days after surgery
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Changes in systemic temperature
Időkeret: baseline
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Fever (systemic) is an indicator of infection.
Because in case of infection pain is usually worse, it may become a bias.
The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).
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baseline
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Changes in dysphagia through a numerical scale
Időkeret: baseline
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The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.
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baseline
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Changes in systemic temperature
Időkeret: Postoperative period: 24 hours after surgery
|
Fever (systemic) is an indicator of infection.
Because in case of infection pain is usually worse, it may become a bias.
The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).
|
Postoperative period: 24 hours after surgery
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Changes in dysphagia through a numerical scale
Időkeret: Postoperative period: 24 hours after surgery
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The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.
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Postoperative period: 24 hours after surgery
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Changes in systemic temperature
Időkeret: Postoperative period: 48 hours after surgery
|
Fever (systemic) is an indicator of infection.
Because in case of infection pain is usually worse, it may become a bias.
The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).
|
Postoperative period: 48 hours after surgery
|
Changes in dysphagia through a numerical scale
Időkeret: Postoperative period: 48 hours after surgery
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The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.
|
Postoperative period: 48 hours after surgery
|
Changes in systemic temperature
Időkeret: Postoperative period: 7 days after surgery
|
Fever (systemic) is an indicator of infection.
Because in case of infection pain is usually worse, it may become a bias.
The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).
|
Postoperative period: 7 days after surgery
|
Changes in dysphagia through a numerical scale
Időkeret: Postoperative period: 7 days after surgery
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The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.
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Postoperative period: 7 days after surgery
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Anna Carolina RT Horliana, phD, Nove de Julho University
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Sampaio-Filho H, Bussadori SK, Goncalves MLL, da Silva DFT, Borsatto MC, Tortamano IP, Longo PL, Pavani C, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Low-level laser treatment applied at auriculotherapy points to reduce postoperative pain in third molar surgery: A randomized, controlled, single-blinded study. PLoS One. 2018 Jun 19;13(6):e0197989. doi: 10.1371/journal.pone.0197989. eCollection 2018.
- Sampaio-Filho H, Sotto-Ramos J, Pinto EH, Cabral MR, Longo PL, Tortamano IP, Marcos RL, Silva DF, Pavani C, Horliana AC. Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial. Trials. 2016 Sep 2;17(1):432. doi: 10.1186/s13063-016-1540-9.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. augusztus 1.
Elsődleges befejezés (Várható)
2016. november 1.
A tanulmány befejezése (Várható)
2017. augusztus 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2016. január 11.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2016. január 12.
Első közzététel (Becslés)
2016. január 15.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2016. január 15.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2016. január 12.
Utolsó ellenőrzés
2016. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 1.100.869
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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