Evaluation of photobiomodulation in salivary production of patients with xerostomy induced by anti-hypertensive drugs: Study protocol clinical trial (SPIRIT compliant)

• Published in: Medicine (Baltimore) Vol. 99; no. 16; p. e19583
• Main Authors: Varellis, Maria Lucia Zarvos, Gonçalves, Marcela Leticia Leal, Pavesi, Vanessa Christina Santos, Horliana, Anna Carolina Ratto Tempestini, de Fátima Teixeira da Silva, Daniela, Motta, Lara Jansiski, Barbosa Filho, Valdomiro F., Bezerra, Cícero Dayves Silva, Silva, Felipe Gonçalves da, Bussadori, Sandra Kalil, Deana, Alessandro M.
• Format: Journal Article
• Language: English
• Published: United States the Author(s). Published by Wolters Kluwer Health, Inc 01-04-2020; Wolters Kluwer Health
• Subjects: Antihypertensive Agents - adverse effects; Double-Blind Method; Humans; Lasers, Semiconductor - therapeutic use; Low-Level Light Therapy; Randomized Controlled Trials as Topic; Saliva - metabolism; Salivation - radiation effects; Study Protocol Clinical Trial; Xerostomia - chemically induced; Xerostomia - metabolism; Xerostomia - radiotherapy
• ISSN: 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000019583

Hypertension (systemic arterial hypertension [SAH]) is a systemic condition that affects about 30% of the world population, according to data from the World Health Organization (WHO). Drugs used to control this disease have the potential to induce xerostomia, an oral condition in which the decrease of the salivary flow is observed and whose presence leads to the increase of the index of caries, periodontal disease, loss of the teeth, dysgeusia, difficulty of mastication, dysphagia, bad breath and oral burning and impairment of prothesis installed in the buccal cavity, including retention of removable and total dentures.
This is a randomized, placebo-controlled, blind clinical protocol that aims to analyze the impact of phobiomodulation (PBM) on salivary glands of patients with antihypertensive drug induced xerostomia. Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30). The irradiation will be made using a diode laser emitting at 808 nm with 100 mW and 40 seconds of exposure per site at the salivary glands. Twenty sites will be irradiated weekly for 4 weeks. Non-stimulated and stimulated salivary flow will be analyzed before and after the treatment.
This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
Clinicaltrials.gov - NCT03632096.