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临床试验/NCT02881827
NCT02881827Unknown不适用

Biochemistry and Volumetric Analysis of Biofluid Salivary, Correlating the Flow, pH and Buffer Capacity With and Without Stimulation of the Masseter Muscle, Before and After Low-level Laser Irradiation

Universidade do Vale do Paraíba2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Increased salivary flow

研究概览

简要总结

The purpose of this study is to obtain experimental data on the possible changes that saliva may suffer when brought to low-level laser therapy protocols for analgesia in the masseter muscle, because this be on the Parotid salivary gland.

详细描述

Climate: The study will be conduced by Lasertherapy and Photobiology Center (CELAFO) at the Institute of Research and Development at the University of Vale do Paraíba (UNIVAP), which was air-conditioned with temperature at 22 ° C.

Volunteers: 30 male volunteers aged between 18 and 30 years.

Flow Analysis Salivary pH and saliva buffer capacity before LLLT and after LLLT: Two consecutive samples of whole saliva were obtained from each second volunteer. The first, unstimulated total saliva (UTS) and the second of stimulated total saliva (STS). Obtaining mechanically given by chewing a paraffin 5cm² fragment. The gathering was held in the afternoon and with the patient in breakfast for at least one hour. All the volunteers were instructed not to brush teeth or use mouthwash for one hour prior to saliva collection of the experiment. The samples were collected UTS and STS requesting voluntary saliva deposited directly into a sterile universal collector. Salivary samples were compared by the universal table salivary flow described by Saliva samples were centrifuged at 1200 rpm for 10 minutes. All saliva volume produced during the 5-minute period was measured using test tubes recorded in milliliters. The pH was measured by a pH meter device. To test the buffer capacity, the saliva (3 mL) was placed in a Falcon tube containing 9 mL of 0,005 normal hydrochloric acid, subjected to manual shaking for 10 seconds, then maintained at rest for 10 minutes with open Falcon tube, aiming evaporation gases such as carbon dioxide which could interfere with the analysis. After 10 minutes the pH was measured with litmus tape aid compared with the color scale provided by the manufacturer.

Low Level Laser Therapy (LLLT): The investigators used the LLLT after the first collection of saliva, control therapies were applied, placebo LLLT red and LLLT in the infrared.The treatment was applied with an interval of 7 days in a randomized, controlled, double-blind, by drawing lots. Irradiation of LLLT was conducted in eight (8) points on the skin in the masseter region. The distance between points was 1cm. To know exactly the location of points, transparency sheets were used (irradiation feedback) and reference points of each volunteer, as follows: point 1 commissure eyelid, point 2 in the tragus of the ear and point 3 on the labial commissure.The anticipated period of 15 minutes to occur the desired effects of LLLT was performed new material collection.

Data Analysis: The salivary flow data, pH and buffering capacity of saliva was analyzed using a analysis program statistics with the nonparametric Kruskal-Wallis test. The significance level was 5% (p <0.05)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Have all dental organs
  • Male volunteers
  • Age between 18 and 30 years
  • Body mass index between 18.5 and 25 (normal) .

排除标准

  • Presence of problems that compromise the physiological activity of the masticatory system
  • Neurological disorders
  • Cerebral Palsy
  • parafunctions :
  • Sucking fingers
  • Nail biting
  • Nibble objects
  • Mouth breathing .
  • Use of medication :
  • Antihistamines
  • Benzodiazepines
  • Depressants of the central nervous system.
  • Temporomandibular dysfunction:
  • Clenching of the teeth
  • Use of partial or full dentures .

结局指标

主要结局

Increased salivary flow

时间窗: 24 months

Expect positive results of this research on the increased salivary flow , improved saliva buffer capacity as well as increased salivary pH enabling a better quality of life for patients.

次要结局

  • Improvement of the salivary pH(24 months)

研究者

发起方
Universidade do Vale do Paraíba
申办方类型
Other
责任方
Sponsor

研究点 (2)

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