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Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study.
Kuba, S, Yamanouchi, K, Matsumoto, M, Maeda, S, Hatachi, T, Sakiko, S, Kawashita, Y, Morita, M, Sakimura, C, Inamasu, E, et al
BMJ open. 2020;(2):e033446
Abstract
INTRODUCTION Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER UMIN Clinical Trials Registry (UMIN000030489).
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A Fatty Acid Mouth Rinse Decreases Self-Reported Hunger and Increases Self-Reported Fullness in Healthy Australian Adults: A Randomized Cross-Over Trial.
Costanzo, A, Russell, CG, Lewin, S, Keast, R
Nutrients. 2020;(3)
Abstract
Fatty acid (FA) chemoreception in the oral cavity, known as fat taste, may trigger a satiety response that is homologous to FA chemoreception in the gastrointestinal tract. In addition, individuals with an impaired fat taste sensitivity are more likely to have an impaired satiety response. This study aimed to assess the effect of an FA mouth rinse on self-reported appetite, and to determine if the effect is modified by fat taste sensitivity. Thirty-one participants (age, 32.0 ± 8.4 y; body mass index (BMI), 26.1 ± 8.1 kg/m2) were studied on four separate days to evaluate the effect of a 20 mM oleic acid (OA) mouth rinse (in duplicate) compared to a control (in duplicate) on self-reported appetite by using a visual analogue scale (VAS) every 30 min for three hours following a standardized low-fat breakfast. The area under the curve ratings for fullness were greater (p = 0.003), and those for hunger were lower (p = 0.002) following the OA rinse compared to the control. The effect of the OA rinse was greater in individuals who were hypersensitive to fat taste compared to moderately sensitive and hyposensitive individuals for fullness (p < 0.010) and hunger (p < 0.010) ratings. In summary, an OA mouth rinse decreases self-reported hunger and increases self-reported fullness, particularly in those who are more sensitive to fat taste. FA receptors in the oral cavity may be potential targets to regulate appetite.
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The effect of Parodontax® on the MMP-8 concentration in gingivitis patients.
Ehlers, V, Helm, S, Kasaj, A, Willershausen, B
Schweizer Monatsschrift fur Zahnmedizin = Revue mensuelle suisse d'odonto-stomatologie = Rivista mensile svizzera di odontologia e stomatologia. 2011;(11):1041-51
Abstract
The aim of the study was to evaluate the efficacy of Parodontax® (GlaxoSmith-Kline, Bühl, Germany) on the signs gingival inflammation and the enzyme activity of matrix metalloproteinase-8 (aMMP-8) in the gingival crevicular fluid. After approval by the ethics commission, a total of 50 volunteers participated in the study; group 1 (n = 25, age: 43 ± 12 years) with moderate gingivitis (BOP +) and group 2 (n = 25, age: 29 ± 11 years) with clinically healthy gingival conditions (BOP -). After obtaining anamnestic data, the dental examination included assessment of oral hygiene (Quigley & Hein 1962), gingival inflammation (Saxer & Mühlemann 1975), probing pocket depth and clinical attachment level. Gingival crevicular fluid was collected from both groups. A quantitative assessment of aMMP-8 in the gingival crevicular fluid samples was performed (DentoAnalyzer, Dentognostics GmbH, Jena, Germany). Study participants were instructed to use only Parodontax®. After three weeks, all parameters were measured again. The aMMP-8 values of group 1 were significantly reduced after the use of Parodontax® toothpaste and mouthwash (p < 0.001; baseline median 41.25 ± 38.16 ng/ml, final post-treatment median 7.73 ± 7.58 ng/ml aMMP-8 eluate; group 2: baseline median 3.75 ± 3.16 ng/ml, final post-treatment median 3.73 ± 1.54 ng/ml aMMP-8 eluate). Gingival inflammation and plaque accumulation were reduced. It was shown that Parodontax® was effective in reducing the enzymatic activity of inflammation.
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Ca pre-rinse greatly increases plaque and plaque fluid F.
Vogel, GL, Schumacher, GE, Chow, LC, Takagi, S, Carey, CM
Journal of dental research. 2008;(5):466-9
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Abstract
Previous studies demonstrated that a Ca pre-treatment greatly increases salivary F from a subsequent NaF rinse. This study examines if these increases are found in plaque and plaque fluid F. Thirteen individuals accumulated plaque before rinsing with: (1) 12 mmol/L NaF (228 microg/g F), (2) 150 mmol/L Ca rinse, or (3) the Ca rinse followed by the F rinse. One hr later, plaque samples were collected, the plaque fluid was recovered, and the plaque residues were extracted 5 times with pH 6.8 or pH 4.8 buffers, and then by acid. The F in each extract after the Ca rinse/F rinse greatly exceeded the corresponding F from the NaF rinse. Consequently, the Ca rinse/F rinse increased the total plaque F and the plaque fluid F by 12x and 5x, compared with the NaF rinse alone. These and the previous salivary results suggest that a Ca pre-treatment may increase the cariostatic effects of topical F agents.
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Assessing the effectiveness of Dead Sea products as prophylactic agents for acute radiochemotherapy-induced skin and mucosal toxicity in patients with head and neck cancers: a phase 2 study.
Matceyevsky, D, Hahoshen, NY, Vexler, A, Noam, A, Khafif, A, Ben-Yosef, R
The Israel Medical Association journal : IMAJ. 2007;(6):439-42
Abstract
BACKGROUND Mucositis and dermatitis are frequently encountered in patients treated with radiochemotherapy. Dead Sea products that contain minerals and other properties have proven effective in treating various skin diseases. OBJECTIVES To evaluate the effectiveness of Dead Sea products in reducing acute radiochemotherapy-induced side effects in patients with head and neck cancer. METHODS In this phase 2 study we compared the outcomes in 24 treated patients and 30 conventionally treated patients matched for age, tumor site, and type of treatment. The Dead Sea products comprised a mouthwash solution (Lenom) and a skin cream (Solaris) used three times daily for 1 week before, during, and up to 2 weeks after completion of radiotherapy. Mucositis and dermatitis were evaluated using common toxicity criteria. RESULTS Thirteen treated patients (54%) had grade 1-2 and none had 3-4 mucositis, while 17 controls (57%) had grade 1-2 and 4 (13%) had grade 3-4 mucositis. Thirteen treated patients (54%) had grade 1-2 dermatitis; there was no instance of grade 3-4 dermatitis, while 11 patients in the control group (37%) had grade 1-2 and 5 (17%) had grade 3-4 dermatitis. More patients in the control arm needed a break than did patients in the treatment the control arm needed a break than did patients in the treatment arm (P = 0.034). CONCLUSIONS The two Dead Sea products tested decreased skin and mucosal toxicity in head and neck cancer patients receiving radiochemotherapy.
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[Effect of mouthwashing with tea tree oil on plaque and inflammation].
Saxer, UP, Stäuble, A, Szabo, SH, Menghini, G
Schweizer Monatsschrift fur Zahnmedizin = Revue mensuelle suisse d'odonto-stomatologie = Rivista mensile svizzera di odontologia e stomatologia. 2003;(9):985-96
Abstract
The tea tree oil (melaleuca alternifolia) has antiseptic, fungicide and bactericide effects. The efficiency against oral bacteria was also evident. Xylitol is known for counterattacking the cariogenic effect caused by the streptococcus mutans. Less plaque was developed during the time of the study.
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Effect of pilocarpine mouthwash on salivary flow.
Bernardi, R, Perin, C, Becker, FL, Ramos, GZ, Gheno, GZ, Lopes, LR, Pires, M, Barros, HM
Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas. 2002;(1):105-10
Abstract
Pilocarpine is a cholinergic agonist that increases salivary flow and has been used to treat xerostomia. Oral intake is the most frequent route of administration. Adverse effects are dose-dependent and include sudoresis, facial blushing and increased urinary frequency. The objective of the present study was to evaluate the effects of topical pilocarpine solutions as mouthwashes on salivary flow and their adverse effects on healthy subjects. Forty volunteers received 10 ml 0.5, 1 and 2% pilocarpine solutions or 0.9% saline in a randomized, double-blind, placebo-controlled manner. Salivation was measured before and 45, 60 and 75 min after mouth rinsing for 1 min with 10 ml of saline or pilocarpine solutions. Vital signs were measured and ocular, gastrointestinal and cardiovascular symptoms, anxiety and flushing were estimated using visual analog scales. There was a dose-dependent increase in salivation. Salivation measured after 1 and 2% pilocarpine (1.4 +/- 0.36 and 2.22 +/- 0.42 g, respectively) was significantly (P<0.001) higher than before (0.70 +/- 0.15 and 0.64 +/- 0.1 g), with a plateau between 45 and 75 min. Cardiovascular, visual, gastrointestinal and behavioral symptoms and signs were not changed by topical pilocarpine. Mouth rinsing with pilocarpine solutions at concentrations of 1 to 2% induced a significant objective and subjective dose-dependent increase in salivary flow, similar to the results reported by others studying the effect of oral 5 mg pilocarpine. The present study revealed the efficacy of pilocarpine mouthwash solutions in increasing salivary flow in healthy volunteers, with no adverse effects. Additional studies on patients with xerostomia are needed.