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NCT04239872
Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. For these individuals, fluoride is used to maintain a good oral health. Usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. In this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. This approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. A crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. The concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.
NCT03874572
An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma
NCT03876197
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.
NCT03151889
Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.
NCT00426543
The primary purpose of the study is to determine whether B-cell depletion with Rituximab has an effect on the oral, ocular and general disease manifestations in patients with primary Sjögren´s syndrome, that is, an effect on the symptoms of oral and ocular dryness, improvement of the glandular function and a beneficial effect on the general symptoms such as fatigue. The secondary purpose of the study is the investigate the underlying autoimmune and pathophysiological mechanisms in Sjögren´s syndrome.
NCT03049943
The aim of this study was to compare the effects of different wave lengths of LLLT on salivation in participants suffering from hyposalivation. This study included 30 participants whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended.
NCT02049112
The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.