Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery

12. januar 2016 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
      • São Paulo, Brasil, 01504-001
        • Rekruttering
        • Nove de Julho University (Uninove)
        • Ta kontakt med:
          • Anna Carolina RT Horliana, PhD
          • Telefonnummer: +5511 3385-9197
          • E-post: annacrth@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 28 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: low level laser in auricular acupuncture points
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.
Placebo komparator: 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.
Enhet: low level laser device off in auricular acupuncture points
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in of post-operative pain by applying a visual analog scale
Tidsramme: baseline
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.
baseline
Change in of post-operative pain by applying a visual analog scale
Tidsramme: 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.
Postoperative period: 24 hours after surgery
Change in of post-operative pain by applying a visual analog scale
Tidsramme: Postoperative period: 48 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.
Postoperative period: 48 hours after surgery
Change in of post-operative pain by applying a visual analog scale
Tidsramme: 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.
Postoperative period: 7 days after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in edema
Tidsramme: baseline
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.
baseline
Changes in mouth opening assessed by the inter-incisor measurement
Tidsramme: baseline
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.
baseline
Changes in local temperature
Tidsramme: baseline
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).
baseline
Changes in edema
Tidsramme: Postoperative period: 24 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: 24 hours after surgery
Changes in mouth opening assessed by the inter-incisor measurement
Tidsramme: 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
Changes in local temperature
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Changes in edema
Tidsramme: Postoperative period: 7 days 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: 7 days after surgery
Changes in mouth opening assessed by the inter-incisor measurement
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in systemic temperature
Tidsramme: baseline
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).
baseline
Changes in dysphagia through a numerical scale
Tidsramme: baseline
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.
baseline
Changes in systemic temperature
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Nove de Julho

Etterforskere

  • Hovedetterforsker: Anna Carolina RT Horliana, phD, Nove de Julho University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Forventet)

1. november 2016

Studiet fullført (Forventet)

1. august 2017

Datoer for studieregistrering

Først innsendt

11. januar 2016

Først innsendt som oppfylte QC-kriteriene

12. januar 2016

Først lagt ut (Anslag)

15. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. januar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. januar 2016

Sist bekreftet

1. januar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1.100.869

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Smerte

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Jamaica

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere