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Low-level Light Therapy clinical trials

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NCT ID: NCT06071637 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application of two wavelengths, red and infrared region in the mouth and neck) in the prevention of oral mucositis and oropharyngeal pain, dysphagia, TPN and opioid use in patients undergoing HSCT allogenic. Materials and methods: This is a phase III, double-blind, randomized study that will use LBP to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). Patients will be included enrolled at the Bone Marrow Transplant Center - Cancer Hospital I - INCA, with indication of allogeneic HSCT, over 18 years old, able to cooperate with the treatment and perform the oral hygiene protocol, who present oral mucosa complete on the first day of conditioning (D-7) and who agree to participate in the study through the term of free and clarified informed consent. The randomization will be carried out in permuted blocks using the REDCap® program by a member of the non-blind team. In group A, extraoral applications will be carried out with the issuance of radiation in the infrared region of the electromagnetic spectrum (808nm) and intraorally in the red region of the electromagnetic spectrum (660nm). In group B, the extra applications and intraoral will be performed with simultaneous double radiation emission in the regions red and infrared of the electromagnetic spectrum (660nm/808nm). for both groups will use the device from DMC (São Carlos, São Paulo, Brazil), with a indium gallium aluminum phosphide (InGaAlP) and aluminum gallium arsiade diode (AlGaAs), with a power of 100mW and a beam area of 0.09842 cm². The LBP will be performed by a dental surgeon, on weekdays, starting on D-7 and end on the day of the "marrow take" (patient presents 500 neutrophils for three days consecutive). The region treated in extraoral applications will be the carotid triangle bilateral, bounded by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior border of the sternocleidomastoid muscle; and intraorally, the mucous membranes right and left cheeks, lower and upper lips, upper and lower labial mucous membranes, right and left lateral borders of the tongue, lingual belly, buccal floor and soft palate. Patients will be evaluated daily (weekdays per week) for oral mucositis, pain in the oral cavity and oropharynx, dysphagia, use of total parenteral nutrition and opioids. Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know about the treatment that the patient will receive. The data from interest will be collected from the physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®. Statistical analyzes will be carried out using the latest available version of the R software for Windows. It will be A descriptive analysis of the data found in the clinical, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the chi-square test of Pearson. Statistical analyzes will be performed using the latest available version of the R software for Windows. A descriptive analysis of the data found will be carried out in clinical examination, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the Pearson's chi-square test. Mucositis-free survival analyzes (any degree) and dysphagia (any degree) will be performed by the Kaplan-Meier method and the curves compared by log-rank test. The time interval between the start of conditioning and date of first grade ≥1 mucositis or dysphagia to date of the "marrow take" (500 neutrophils in the peripheral blood for three consecutive days). Participants without mucositis or dysphagia will be censored on the date of marrow collection. Tests of hypothesis with p-value < 0.05. The sample calculation predicted 82 patients, who will be evaluated by intention of treatment, counting with 10% loss to reach 37 patients in group A and 37 in group B. The estimate of the presence of oral mucositis grades 2, 3 and 4 in group A is 36.8% and in group B 10%. The estimate of the presence of dysphagia grades 3 and 4 (or pain in oropharynx grades 2 and 3) in group A is 80% and in group B 40%. the statistical test The two-tailed Z test with pooled variance was used, with a type 1 error of 0.05 and the error type 2 of 0.20. This research project was approved by the Research Ethics Committee responsible (CAAE 67172223.9.0000.5274, opinion No. 5.947.434) and will be conducted in a according to Resolution 466/12 of the National Health Council and the Good News Guide Clinical Practices.

NCT ID: NCT05336981 Completed - Photobiomodulation Clinical Trials

Effect of Photobiomodulation for Patients With Xerostomia

xeros
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life. The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation

NCT ID: NCT05252260 Completed - Wound Heal Clinical Trials

Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique

NCT ID: NCT04202900 Completed - Clinical trials for Low Level Light Therapy

Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

The world is facing rapid population aging, the health needs of the elderly are complex, and their physical capabilities are degraded, and increased the possibility of having one or more chronic conditions. In 1900 to 2000, there were 7,600 million people in the United States, aged 65 and above age increased to 4.1% up to 12.6%, by 2050 is expected to increase 20.3%.In Taiwan, the elderly population have 83.5% is health and sub-health, in order to allow them to perform activities of daily living independently, in particular, need to pay attention to the diverse needs of the elderly, Assist the elderly to increase self-care skills, reduce disability is a very important issue.

NCT ID: NCT04036539 Completed - Clinical trials for Low-Level Light Therapy

Photobiomodulation on Molar Verticalization With Mini-implant

Start date: November 15, 2020
Phase: N/A
Study type: Interventional

The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues. Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM (photobiomodulation) simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm (nanometers), 100mW (milliwatts), receiving 1J(joule) per point, 10s (seconds), 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The crevicular gingival fluid (FGC) will be collected to analyzed Interleukins IL1β, IL-6, IL-8, IL-10(Interleukins) and TNF-α (tumor necrosis factor) by ELISA (enzyme-linked immunosorbent assay). Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 (oral health impact profile) questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD(standard deviation) and the value of p will be defined as <0.05.

NCT ID: NCT04006717 Active, not recruiting - Clinical trials for Low-level Light Therapy

Comparison Between Low-level Laser Therapy, Intracanal Cryotherapy and Their Combination, on Post-endodontic Pain Level

Start date: June 24, 2019
Phase: N/A
Study type: Interventional

Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of painful situations. Aim of the study: This study is conducted to clinically evaluate and compare the effect of both LLLT and ICCT on post-endodontic pain (PEP) over 5 days in molars with symptomatic apical periodontitis (SAP) using visual analog scale (VAS). Materials & Methods: This parallel arm, randomized clinical trial will involve 95 systemically free patients with SAP in molars. The patients will be randomly allocated to 5 equal groups as follows: control (no intervention), placebo (mock laser therapy), LLLT, ICCT and a combination of both. Postoperative pain levels after 6 hrs, 12 hrs, on 2nd day and 5th day are going to be assessed on the VAS and shall be noted. Data collected will be tabulated and statistically analysed.

NCT ID: NCT03425695 Completed - Wounds and Injuries Clinical Trials

Free Gingival Graft Adjunct With Low Level Laser Therapy

Start date: June 2016
Phase: N/A
Study type: Interventional

The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.

NCT ID: NCT03320460 Recruiting - Lichen Planus, Oral Clinical Trials

Photobiomodulation in Oral Lichen Planus

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).

NCT ID: NCT03250715 Completed - Clinical trials for Renal Insufficiency, Chronic

Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

This study aims to verify the effects of low level laser therapy (LLLT) on functional capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized into two groups: the control group and the LLLT group. The control group will only be evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT three times a week for eight weeks during HD. The evaluations will be performed pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation will be performed only at pre intervention and after 8 weeks. The evaluations carried out are: six-minute walk test for functional capacity; alkaline comet assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of lower limbs muscle strength; quadriceps ultrasonography for muscle architecture and echogenicity; visual analogue scale for pain; subjective perception of effort by Borg scale for fatigue; measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein and muscle damage markers (lactate, creatine kinase) for the inflammatory profile; protein carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein diacetate for oxidative stress and application of the Kidney Disease and Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.

NCT ID: NCT03229330 Completed - Venous Ulcer Clinical Trials

Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)

LASERUVe
Start date: April 2016
Phase: N/A
Study type: Interventional

This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.