Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery
Effectiveness of Low Level Laser at the Auriculotherapy Points, in Reducing Postoperative Pain in Third Molar Surgery
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Oczekiwany)
Zapisy
Faza
Faza
- Faza 4
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Anna Carolina RT Horliana, PhD
- E-mail: annacrth@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Helio S Filho, Ms
- E-mail: heliosampaiofilho@gmail.com
Lokalizacje studiów
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São Paulo, Brazylia, 01504-001
- Rekrutacyjny
- Nove de Julho university (UNINOVE)
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Kontakt:
- Anna Carolina RT Horliana, PhD
- Numer telefonu: +5511 3385-9197
- E-mail: annacrth@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: 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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Komparator placebo: 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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in of post-operative pain by applying a visual analog scale
Ramy czasowe: 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
Ramy czasowe: Postoperative period: 24 hours 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: 24 hours after surgery
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Change in of post-operative pain by applying a visual analog scale
Ramy czasowe: 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.
|
Postoperative period: 48 hours after surgery
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Change in of post-operative pain by applying a visual analog scale
Ramy czasowe: 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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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in edema
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Postoperative period: 24 hours after surgery
|
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Changes in mouth opening assessed by the inter-incisor measurement
Ramy czasowe: 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.
|
Postoperative period: 24 hours after surgery
|
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Changes in local temperature
Ramy czasowe: Postoperative period: 24 hours after surgery
|
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).
|
Postoperative period: 24 hours after surgery
|
|
Changes in edema
Ramy czasowe: Postoperative period: 48 hours after surgery
|
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: 48 hours after surgery
|
|
Changes in mouth opening assessed by the inter-incisor measurement
Ramy czasowe: 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.
|
Postoperative period: 48 hours after surgery
|
|
Changes in local temperature
Ramy czasowe: Postoperative period: 48 hours after surgery
|
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).
|
Postoperative period: 48 hours after surgery
|
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Changes in edema
Ramy czasowe: 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
|
|
Changes in mouth opening assessed by the inter-incisor measurement
Ramy czasowe: 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.
|
Postoperative period: 7 days after surgery
|
|
Changes in local temperature
Ramy czasowe: Postoperative period: 7 days after surgery
|
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).
|
Postoperative period: 7 days after surgery
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in systemic temperature
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Changes in systemic temperature
Ramy czasowe: 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
|
|
Changes in dysphagia through a numerical scale
Ramy czasowe: Postoperative period: 24 hours after surgery
|
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: 24 hours after surgery
|
|
Changes in systemic temperature
Ramy czasowe: 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
Ramy czasowe: Postoperative period: 48 hours after surgery
|
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
Ramy czasowe: 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
Ramy czasowe: Postoperative period: 7 days after surgery
|
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: 7 days after surgery
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Anna Carolina RT Horliana, phD, Nove de Julho University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Zakończenie podstawowe
Ukończenie studiów (Oczekiwany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 1.100.869
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