- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02657174
Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery
2016년 1월 12일 업데이트: 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.
연구 개요
상태
알려지지 않은
정황
상세 설명
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.
연구 유형
중재적
등록 (예상)
80
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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São Paulo, 브라질, 01504-001
- 모병
- Nove de Julho university (UNINOVE)
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연락하다:
- Anna Carolina RT Horliana, PhD
- 전화번호: +5511 3385-9197
- 이메일: annacrth@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in of post-operative pain by applying a visual analog scale
기간: 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.
|
baseline
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Change in of post-operative pain by applying a visual analog scale
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in edema
기간: 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
기간: 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
기간: 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
기간: 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
|
|
Changes in mouth opening assessed by the inter-incisor measurement
기간: 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
기간: 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).
|
Postoperative period: 24 hours after surgery
|
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Changes in edema
기간: 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.
|
Postoperative period: 48 hours after surgery
|
|
Changes in mouth opening assessed by the inter-incisor measurement
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
|
Postoperative period: 7 days after surgery
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in systemic temperature
기간: 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
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Changes in dysphagia through a numerical scale
기간: 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.
|
baseline
|
|
Changes in systemic temperature
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Anna Carolina RT Horliana, phD, Nove de Julho University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 8월 1일
기본 완료 (예상)
2016년 11월 1일
연구 완료 (예상)
2017년 8월 1일
연구 등록 날짜
최초 제출
2016년 1월 11일
QC 기준을 충족하는 최초 제출
2016년 1월 12일
처음 게시됨 (추정)
2016년 1월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 1월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 1월 12일
마지막으로 확인됨
2016년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .