Photobiomodulation on the Salivary Glands of Patients With Xerostomia

Status Recruiting

Clinical Trial Summary

Depression is the most common mental illness and antidepressants are in the first line of treatment of depressed patients. This therapeutic class is inevitably associated with side effects and adverse reactions, xerostomia being a symptom that seems to be transverse to them all. Saliva performs multiple functions and plays a vital role in protecting the health of the soft and hard tissues of the oral cavity. Reductions in salivary flow are most often manifested as dry mouth, and this is the subjective complaint called xerostomia. Although xerostomia is the most frequent indication of reduced salivary production, it is not invariably associated with hyposalivation. The user of antidepressant drugs has a number of important systemic and oral complications. Treatment for salivary changes remains unknown, but low-level laser therapy has been shown to be effective in improving salivary flow in patients with xerostomia due to diabetes, Sjogren's syndrome, chemotherapy and radiotherapy for head, neck and lung cancer. This randomized controlled trial aims to evaluate oral symptoms related to salivary gland function and mucosal condition of depressed patients, as well as the effects of photobiomodulation on salivary flow. Sixty patients will be included in the protocol, after signing the Informed Consent Form. They will undergo anamnesis, physical evaluation and oral health self-perception questionnaires and symptoms related to salivary gland function and then will be divided into two groups: Photobiomodulation (PBM) (n=30); will have their larger salivary glands irradiated with Diode laser (808nm, 4J per point, 40s) and placebo (PCB) (n=30), which will be subjected to a simulation, where the application protocol will be repeated, but with the laser off. Previous and post treatment sialometries will be performed to compare saliva volume. Biochemical analysis, in which total protein and calcium will be measured, will also be performed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Xerostomia

Clinical Trial Details

NCT number	NCT05443022
Study type	Interventional
Source	University of Nove de Julho
Contact	Sandra K Bussadori, PhD
Phone	+55 11 2633-9000
Email	sandra.skb@gmail.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	February 20, 2022
Completion date	June 20, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05342272` - Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction	Phase 3
Completed	`NCT03302676` - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors	N/A
Completed	`NCT02375451` - Effect of Childhood Radioiodine Therapy on Salivary Function	N/A
Completed	`NCT01272570` - Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors	N/A
Completed	`NCT00656513` - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer	Phase 2/Phase 3
Completed	`NCT00911768` - Effect of Korean Red Ginseng (KRG) on Dry Mouth	Phase 4
Completed	`NCT00332618` - Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia	Phase 2
Completed	`NCT03494985` - A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water	N/A
Completed	`NCT05058430` - SaliPen Human Factors Study for OTC Labeling	N/A
Recruiting	`NCT02705937` - Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.	N/A
Completed	`NCT05247008` - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD	N/A
Recruiting	`NCT03632096` - Photobiomodulation in Salivary Production of Patients With Xerostomy	Phase 2
Not yet recruiting	`NCT04323384` - The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing	N/A
Not yet recruiting	`NCT03530735` - Finger-prick Autologous Blood (FAB) for Use in Dry Mouth	N/A
Active, not recruiting	`NCT03176368` - Coconut Oil: Managing Radiation-Induced Xerostomia	N/A
Enrolling by invitation	`NCT06122636` - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC	N/A
Completed	`NCT03611283` - Topical Management of Xerostomia With Dry Mouth Products	N/A
Completed	`NCT02682199` - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn	`NCT01960101` - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication	N/A
Completed	`NCT02317172` - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Photobiomodulation on the Salivary Glands of Patients With Xerostomia Induced by the Use of Benzodiazepines

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms