Assessment of a combined mouthwash on pain relief in pericoronitis: a randomized clinical study.

BACKGROUND: Pericoronitis, an inflammation near wisdom teeth, often occurs when they are partially emerged, especially in the lower jaw. Commonly, the gingiva partially envelops the tooth. Treatments vary from gingival surgery to extraction. This study assessed the efficacy of a mouthwash with Chlorhexidine, Benzydamine, Nanosilver, Amoxicillin, and Metronidazole for pain reduction and enhancement of maximum mouth opening in acute pericoronitis cases. MATERIALS AND METHODS: In this randomized controlled clinical trial conducted at the Gorgan Dental Faculty, 48 pericoronitis patients were randomized into two groups. The control group used a 0.12% chlorhexidine mouthwash, while the case group used a mouthwash containing Chlorhexidine, Benzydamine, Nanosilver, Amoxicillin, and Metronidazole. The study recorded Visual Analog Scale (VAS) scores for 7 days, and Maximum mouth opening (MMO) was measured at the start and after 7 days. The analysis was performed using SPSS v20. RESULTS: In this study, we compared the effects of a combined mouthwash with those of a chlorhexidine mouthwash on pericoronitis in 48 patients, with an average age of 21.56 years. No significant difference in pain reduction was observed between the groups; however, both groups exhibited decreased pain and improved MMO post-treatment. The gender distribution was balanced across both groups. CONCLUSION: The results indicate that both chlorhexidine mouthwash and combined mouthwash significantly improved maximum mouth opening. Nonetheless, there were no notable differences in efficacy between the two groups. These findings suggest that these mouthwashes may be beneficial for oral hygiene, warranting further in-depth research. TRIAL REGISTRATION: Registered on 12/03/2023, registration number IRCT20230104057046N1.

Rebamipide gargle and benzydamine gargle in prevention and management of chemo-radiotherapy and radiotherapy-induced oral mucositis in head and neck cancer patients (randomized clinical trial).

OBJECTIVES: This study aimed to evaluate the preventive and therapeutic effects of rebamipide gargle in comparison with benzydamine in head and neck cancer patients undergoing radiotherapy with or without chemotherapy. MATERIALS AND METHODS: Phase III randomized clinical trial was conducted from January 2021 till August 2022 on one hundred patients with head and neck cancer receiving high doses of radiotherapy. These patients were equally allocated into either rebamipide group or benzydamine group, The measured outcomes were the incidence of oral mucositis ≥ grade1, according to the WHO mucositis scale, in addition to the duration, and the onset of oral mucositis. RESULTS: There was no statistically significant difference between the two groups, regarding the incidence of a severe grade of oral mucositis (WHO grades 3), as well as the onset and duration of oral mucositis. Both gargles succeeded to prevent the development of WHO grade 4 oral mucositis. Side effects reported were mainly burning sensation in benzydamine group and nausea in rebamipide group. CONCLUSION: Rebamipide mouthwash was as beneficial as benzydamine mouthwash in minimizing the incidence of severe oral mucositis induced by treatment of head and neck cancer. However, rebamipide gargle proved to be superior to benzydamine in terms of reduction in the severity of the radiation-induced oral mucositis. TRIAL REGISTRATION: The trial was registered in the protocol Registration and Result system of Clinical Trials (Registration ID: NCT04685395)0.28-12-2020.

Efficacy of natural enzymes mouthwash: a randomised controlled trial.

OBJECTIVES: Natural enzymes mouthwash has been proposed as salivary substitutes to treat xerostomia. This study aims to evaluate the efficacy of the mouthwash to treat xerostomia. MATERIALS AND METHODS: A double-blind, parallel group randomised control clinical trial involving N = 49 adult participants with xerostomia was carried out. Intervention group received natural enzymes moisturising mouthwash (with active ingredients lactoferrin, lysozyme, lactoperoxidase and glucose oxidase); while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code, and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Symptoms of xerostomia were assessed using Xerostomia Inventory at day 0 and 14; together with the assessment of Clinical Oral Dryness Score (CODS), and measurement of resting and stimulated salivary flow rate. RESULTS: 48 participants completed the clinical follow-up, and n = 1 had lost of follow-up. From the 48 participants, n = 23 received natural enzymes mouthwash, while n = 25 received benzydamine mouthwash. Intervention group achieved reduction in symptoms of xerostomia from baseline. Intervention group also showed significantly better improvements in the cognitive perception of dry mouth and oromotor function such as chewing, swallowing and speech of the participants; and reduction in waking up at night to drink water (p < 0.05). The CODS and resting salivary flow rate were also significantly improved in intervention group (p < 0.05). CONCLUSION: Use of natural enzymes mouthwash improved signs and symptoms of xerostomia. CLINICAL RELEVANCE: Natural enzymes mouthwash is potentially effective to treat xerostomia, well-tolerated and safe to be used by xerostomia patients. CLINICAL TRIAL REGISTRATION NUMBER: This study was retrospectively registered in ClinicalTrials.gov ID NCT05640362 on 7 December 2022.

Benzydamine plays a role in limiting inflammatory pain induced by neuronal sensitization.

Benzydamine is an active pharmaceutical compound used in the oral care pharmaceutical preparation as NSAID. Beside from its anti-inflammatory action, benzydamine local application effectively reliefs pain showing analgesic and anaesthetic properties. Benzydamine mechanism of action has been characterized on inflammatory cell types and mediators highlighting its capacity to inhibit pro-inflammatory mediators' synthesis and release. On the other hand, the role of benzydamine as neuronal excitability modulator has not yet fully explored. Thus, we studied benzydamine's effect over primary cultured DRG nociceptors excitability and after acute and chronic inflammatory sensitization, as a model to evaluate relative nociceptive response. Benzydamine demonstrated to effectively inhibit neuronal basal excitability reducing its firing frequency and increasing rheobase and afterhyperpolarization amplitude. Its effect was time and dose-dependent. At higher doses, benzydamine induced changes in action potential wavelength, decreasing its height and slightly increasing its duration. Moreover, the compound reduced neuronal acute and chronic inflammatory sensitization. It inhibited neuronal excitability mediated either by an inflammatory cocktail, acidic pH or high external KCl. Notably, higher potency was evidenced under inflammatory sensitized conditions. This effect could be explained either by modulation of inflammatory and/or neuronal sensitizing signalling cascades or by direct modulation of proalgesic and action potential firing initiating ion channels. Apparently, the compound inhibited Nav1.8 channel but had no effect over Kv7.2, Kv7.3, TRPV1 and TRPA1. In conclusion, the obtained results strengthen the analgesic and anti-inflammatory effect of benzydamine, highlighting its mode of action on local pain and inflammatory signalling.

Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial.

BACKGROUND: Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard) and a new combination (sumac and rose water) in preventing radiation-induced OM. METHODS: This was a phase II, triple-blind, active-controlled, randomized trial. The primary endpoint was OM, and the secondary endpoints were oral pain and QoL. Besides, the possible variables defining the outcomes were analyzed using the chi-squared test (univariate analysis) and binomial regression model (multivariate analysis). RESULTS: Sumac-rose group had fewer high-grade OM (33% vs. 63%, odds ratio [OR] 0.28, 95% confidence interval [CI 95%] 0.08-0.93, P = 0.03) and better QoL (P < 0.05). Multivariate analysis confirmed these findings. Sumac-rose rinsing could also postpone the start of oral pain (hazard ratio [HR] 0.02, CI 95% 0.001-0.32, P = 0.001) and high-grade OM (HR 0.28, P = 0.03) compared with benzydamine. CONCLUSIONS: The sumac-rose group had a lower OM rate and grade and higher QoL than the benzydamine group. In addition, the experimental group developed high-grade OM and oral pain later during the radiotherapy course. Further studies need to be conducted to assess the role of sumac and rose water in reducing grade 3-4 mucositis in patients who undergo chemoradiation for head and neck cancer.

Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial.

BACKGROUND: Acute sore throat (ST) can occur as part of a common cold of viral origin or caused by pharyngeal bacterial pathogens. The majority of patients with acute ST complain of pain on swallowing and dry scratchiness which can have a negative impact on the quality of life (QoL). This study aimed to evaluate the time to pain relief in patients with acute ST, following a single administration of benzydamine hydrochloride (HCl) 0.3% oromucosal spray or benzydamine HCl 3 mg lozenges. METHODS: This multicenter, randomized, active-controlled, open label, parallel-group, international phase IV study was conducted at 12 investigational centers in Poland, Hungary, and Russian Federation. The study population consisted of 363 adult patients with recent onset (≤3 days) of ST and a diagnosis of tonsillopharyngitis. The primary endpoint was to assess the efficacy of benzydamine HCl in ST pain relief at 2 minutes after a single-dose administration. Secondary endpoints included, among others, the assessment of a first perceived ST relief at 1 minute after a single-dose administration of benzydamine HCl spray or lozenge. RESULTS: Both the spray and lozenges are effective in providing a ST relief starting already at 2 minutes after a single administration, with an effect lasting up to up to 4 hours. Clinical efficacy after 7 days of treatment and a good safety profile were also demonstrated. CONCLUSION: Anesthetic and analgesic properties of benzydamine spray and lozenges effectively addressed the patient priority of a rapid relief of symptoms of upper respiratory tract infections (URTI).

Randomized Control Study of the Effects of Turmeric Mouthwash on Oral Health Status, Treatment-Induced Mucositis, and Associated Oral Dysfunctions Among Patients With Head and Neck Cancer.

BACKGROUND: Oral mucositis is the most severe and debilitating adverse effect of cancer treatment, resulting in inadequate nutritional intake, treatment disruptions, and dose alteration, leading to increased hospital costs and decreased tumor control. OBJECTIVE: The aim of this study was to determine the effectiveness of turmeric mouthwash on oral health status and onset and severity of treatment-induced oral mucositis and associated oral dysfunctions among head and neck cancer patients. METHODS: A randomized controlled design was adopted (CTRI/2018/06/014367). Turmeric mouthwash was administered to the experimental group (n = 46) and benzydamine mouthwash was given to the control group (n = 46). Oral health status and mucositis were graded using the Oral Health Assessment Tool and the World Health Organization oral toxicity criteria, respectively. Oral dysfunctions were measured by a patient-reported oral mucositis symptom scale and xerostomia short-form inventory. All outcome variables were measured weekly during the entire course of radiation therapy. RESULTS: Both groups were comparable with regard to their demographic and outcome variables ( P > .05). The incidence of intolerable mucositis in the control group was 100% compared with 17.8% in the experimental group. Repeated-measures analysis of variance demonstrated significant differences in the onset and severity of oral mucositis ( P = .001), oral health status ( P = .001), and oral dysfunctions ( P = .001) between the experimental and control groups. CONCLUSION: Turmeric mouthwash was effective in reducing the severity of oral mucositis and associated oral dysfunctions as compared with benzydamine mouthwash. IMPLICATIONS: Use of turmeric, a nontoxic and cost-effective intervention, can be an alternative to the traditional management of oral mucositis.

Potential therapeutic effects of different mouthwashes for alleviation and treatment of oral complications of 5-fluorouracil-based chemotherapy in patients with colon cancer.

OBJECTIVE: The primary endpoint of the present study was to assess the potential therapeutic effects of three different mouthwashes for alleviation and treatment of oral complications (OCs). The secondary endpoint was to assess patients' perceptions and daily functional activities after therapy of OCs in patients with colon cancer receiving 5-fluorouracil (5-FU)-based chemotherapy regimens. METHODS: A prospective, randomised controlled study carried out on 90 patients with colon cancer eligible for 5-FU-based chemotherapy regimens at the oncology centre, Istanbul, Turkey. Patients were randomly randomised into three groups (30 patients in each group) and received a single mouthwash. The first group (group A) received benzydamine at a dose of 15 mL; the second group (group B) received sodium bicarbonate at a dose of 1.2-2.4 g in 240 mL of water; and the third group (group C) received glutamine suspension 10 g. Patients were assessed for the occurrence of oral complications based on the WHO scale for oral mucosa evaluation and National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Oral pain was assessed using a visual analogue scale alongside assessment of patients' perceptions and daily functional activities based on the Rotterdam Symptom Checklist. RESULTS: A total of 119 oral complications were reported, including mouth dryness (n=56, 47.1%), oral mucositis (n=31, 26.1%) and oral pain (n=32, 26.8%). At the end of the study, patients of group A and group B significantly suffered from mouth dryness (p=0.0001), oral mucositis (p=0.029) and oral pain (p=0.039) compared with patients in group C. Although there was no significant change, group C patients showed a slight improvement in psychological discomfort, activity levels and quality of life at the end of the study. CONCLUSION: The present study showed that benzydamine and sodium bicarbonate mouthwashes were significantly less effective for the alleviation and treatment of oral complications compared with glutamine among patients with colon cancer receiving 5-FU-based chemotherapy regimens.

[Efficiency of benzydamine use in treatment of URTI (including COVID-19) in child patients]. / Klinicheskie rezul'taty kuratsii patsientov detskogo vozrasta s porazheniem respiratornogo trakta pri ostrykh respiratornykh virusnykh infektsiyakh (vklyuchaya COVID-19).

THE AIM: Share with healthcare practitioners personal experience of using benzydamine spray (Oralsept) in pediatric practice; present a clinical case, which, according to the author, can help doctors optimize approaches to the treatment of patients with acute respiratory viral infections (including COVID-19), thereby improving the quality of life of pediatric patients.

Benzydamine hydrochloride for the treatment of sore throat and irritative/inflammatory conditions of the oropharynx: a cross-national survey among pharmacists and general practitioners.

BACKGROUND: Benzydamine for oromucosal use is indicated in the relief of pain and irritation of the mouth and throat. It is an indazole derivative, non-steroidal anti-inflammatory drug, with combined local anesthetic and analgesic properties, and antiseptic activity, marketed under the brand name "Tantum Verde". The aim of this study was to explore knowledge and prescriptive/advising attitudes among general practitioners (GPs) and pharmacists (PHs) with regard to the topical treatment of sore throat and other irritative/inflammatory conditions of the oropharynx, with a focus on benzydamine. These findings could be important to increase awareness on benzydamine efficacy in sore throat and stomatological conditions, and to reinforce knowledge on the characteristics of benzydamine and its mechanisms of action among healthcare professionals (pediatricians, otolaryngologists, oncologists, etc.). MATERIALS AND METHODS: An online questionnaire survey was performed among PHs and GPs in four European countries (Italy, Germany, Russia and Poland). RESULTS: Both GPs and PHs proved to have an excellent knowledge and mastery of the constituents effective against oral symptoms. Among all the principles, benzydamine hydrochloride is the most recognized as certainly suitable for the topical treatment of sore throat symptoms and various inflammatory/irritative conditions of the oral cavity. It is recommended by about 90% of PHs and prescribed by 80% of GPs, mainly to solve the ailments caused by sore throats and stomatitis, especially for its anti-inflammatory, analgesic and anesthetic characteristics. Also in the pediatric field, benzydamine hydrochloride is recommended: among GPs, a high percentage (about 40%) prescribes it like the remedies based on dichlorobenzyl alcohol-sodium benzoate, which are instead more often recommended by PHs (44% against 37%). CONCLUSION: Although the public has a lot of confidence in this treatment, GPs and PHs do not recommend/prescribe benzydamine as a first-line treatment of sore throat and other irritative/inflammatory conditions of the oropharynx. To increase the knowledge of benzydamine among these healthcare professionals, it would be important to emphasize its characteristics and the different irritative/inflammatory conditions of the oropharynx in which it can be used.

The role of benzydamine in prevention and treatment of chemoradiotherapy-induced mucositis.

PURPOSE: To discuss the role of benzydamine in the prevention and treatment of radiation-induced oral mucositis (OM) in head and neck (H&N) cancer patients. This document represents an expert opinion paper on indications and key-role aspects in OM pathogenesis, prevention and treatment. ORAL MUCOSITIS: OM represents a common side effect of chemotherapy (CHT) and radiotherapy (RT). It consists in a painful erythema involving the oral cavity mucosa, which may progress to ulceration. Five biologically dynamic phases are considered crucial in mucositis: "initiation, signalling, amplification, ulceration and healing". Oral environment and microbiota are fundamental in mucositis development being involved in susceptibility to infections and in ulceration consequences. Different agents against mucositis have been studied and the use of benzydamine is strongly supported in literature. The Multinational Association of Supportive Care in Cancer and International Society for Oral Oncology (MASCC/ISOO) guidelines recommend its use for the prevention of OM in H&N patients undergoing RT and RT/CHT. BENZYDAMINE: Benzydamine is a local anti-inflammatory drug with analgesic properties. It can decrease TNF-α, IL-1ß and prostaglandin synthesis, also inhibiting leukocyte-endothelial interactions, neutrophil degranulation, vasodilation and vascular permeability. Literature agrees on the beneficial effects of benzydamine in preventing and reducing oral mucositis severity in H&N cancer patients undergoing RT/CHT. CONCLUSIONS: Mucositis represents a major concern in H&N cancer patients and a clinical and economical issue. A multimodal and multidisciplinary approach is needed for its management. International guidelines recommend benzydamine for OM prevention and treatment in H&N cancer patients, but further "real world" trials should be designed.

Effect of Honey-Lemon Spray Versus Benzydamine Hydrochloride Spray on Radiation-Induced Acute Oral Mucositis in Head and Neck Cancer Patients: A Pilot, Randomized, Double-Blind, Active-Controlled Clinical Trial.

Introduction: Oral mucositis (OM) is the most prevalent side effect in patients with head and neck cancer (HNC). It causes an obvious decrease in quality of life (QoL) in these patients, so different medications have been recommended for OM, however, without optimal response. This randomized trial aimed to assess the effects of a honey-lemon spray compared with benzydamine hydrochloride in prevention of radiation-induced OM in patients with HNC. Materials and Methods: Forty-six patients with HNC received external beam radiotherapy for 5 days per week. Patients were randomized to treatment with either benzydamine hydrochloride spray or honey-lemon spray for 5 weeks and continued for 1 week after the end of treatment. The oral cavity was examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and a mean mucositis score was calculated as the primary outcome. Occurrence of OM, pain, QoL, and adverse effects were defined as secondary outcomes. Patients, therapists, and outcome assessors were blinded to group allocation. Results: No significant group differences occurred in the mucositis score, pain, or QoL. Mucositis occurrence rates were higher in the benzydamine hydrochloride group compared with the honey-lemon group (hazard ratio = 2.1, 95% confidence interval: 1.1 to 4.2). Two patients in the honey-lemon group had mild nausea and burning throat; no adverse effects occurred in the benzydamine hydrochloride group. Conclusions: There were no significant group differences in mucositis severity between patients treated with honey-lemon spray and benzydamine hydrochloride. The potential preventive effects of honey-lemon spray need to be confirmed in further trials. The trial registration number is IRCT20161024030467N1.

The effects of topical chlorhexidine-benzydamine spray on laryngeal mask airway application.

BACKGROUND: Laryngeal mask airway (LMA) use is very common during anesthesia practice. Sore throat, earache, hoarseness and swallowing difficulties may occur on LMA insertion. The primary aim of this study was to describe the effects of topical application of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride (Kloroben® oral spray, 30 mL) on postoperative sore throat due to LMA use. The secondary aims were to evaluate earache, swallowing difficulty, nausea and vomiting and the hemodynamic responses due to LMA insertion and the incidence of coughing, tooth clenching, desaturation and laryngeal spasms during LMA removal. METHODS: After obtaining Institutional Ethics Committee approval and written informed consent (Ref no 29/15), a total of 100 adult patients were included. In Group C, four puffs of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride were applied to the nasopharyngeal area 15 min before surgery. In Group S, 0.9% saline was applied, using the same protocol. RESULTS: When both groups were compared, more patients in Group S had cough, sore throat and swallowing difficulties one hour after surgery (P<0.05), but there was no statistically significant difference at 6, 12, and 24 h between the two groups (P>0.05). The incidence of nausea, vomiting, and earaches was similar in both groups at all measurement times (P>0.05). CONCLUSIONS: Preemptive topical benzydamine hydrochloride and chlorhexidine gluconate in a spray formula may decrease the incidence of sore throat, cough and swallowing difficulties associated with LMA use.

Effect of chlorhexidine/benzydamine soaked pharyngeal packing on throat pain and postoperative nausea & vomiting in orthognathic surgery.

Pharyngeal packing is believed to reduce postoperative nausea and vomiting (PONV) frequency, but has the disadvantage of causing throat pain. The present study aimed to investigate whether applying pharyngeal packs soaked with a combination of chlorhexidine gluconate 0.2% and benzydamine hydrochloride 0.15% (CGBH) were effective in preventing postoperative throat pain and PONV in patients undergoing orthognathic surgery. A total of 101 patients scheduled for orthognathic surgery were enrolled in this prospective, double-blind, randomized study. Patients were randomly allocated into two groups: those with CGBH-soaked packing, and those with saline-soaked pharyngeal packing. PONV was recorded using a 5-point Likert scale (0: no PONV to 4: severe PONV) immediately after the surgery at 5, 10, and 30 min, and at 2, 4, 6, 12, and 24 h postoperatively. The severity of throat pain was assessed via two methods: visual analogue scale (VAS, 0: no pain, 10: severe pain) and 6-point Likert scale (0: no pain, 5: strongly severe pain) score at 2, 4, 6, 12, and 24 h postoperatively. Mean VAS scores of throat pain were significantly lower in patients receiving CGBH-soaked pharyngeal packs compared to patients receiving saline-soaked pharyngeal packs, at all measured time points. There was a tendency towards less PONV in patients receiving a CGBH-soaked pharyngeal pack compared to those receiving a saline-soaked pharyngeal pack; however, this difference did not reach statistical significance. The results of this study suggest that the usage of CGBH-soaked pharyngeal packs reduce postoperative throat pain in patients undergoing orthognathic surgery. Our results support the implementation of CGBH-soaked pharyngeal packing in orthognathic surgery practice, as a measure to improve patient comfort.

Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients and clinical practice guidelines.

PURPOSE: The aim of this systematic review was to update the clinical practice guidelines for the use of anti-inflammatory agents in the prevention and/or treatment of oral mucositis. METHODS: A systematic review was conducted by the Multinational Association of Supportive Care in Cancer/ International Society of Oral Oncology (MASCC/ISOO) subcommittee on mucositis guideline update. The body of evidence for each intervention, in each cancer treatment setting, was assigned an evidence level. The findings were added to the database used to develop the clinical practice guidelines published in 2014. Based on the evidence level, one of the following three guideline determinations was possible: recommendation, suggestion, and no guidelines. RESULTS: A total of 11 new papers across five interventions were examined. The recommendation for the use of benzydamine mouthwash for the prevention of radiotherapy-induced mucositis remained unchanged. New suggestion for the use of the same for prevention of mucositis associated with chemoradiotherapy was made. No guideline was possible for any other anti-inflammatory agents due to inadequate and/or conflicting evidence. CONCLUSIONS: Of the anti-inflammatory agents studied for oral mucositis, the evidence supports the use of benzydamine mouthwash in the specific populations listed above. Additional well-designed research is needed on other (class of agents) interventions and in other cancer treatment settings.

The effect of three different solutions on preventing oral mucositis in cancer patients undergoing stem cell transplantation: a non-randomized controlled trial: A Turkish study - NON-RANDOMISED TRIAL.

OBJECTIVE: To evaluate the effect of different solutions administered to patients undergoing stem cell transplantation on oral mucositis. METHODS: The non-randomised controlled trial was conducted at a Istanbul Medipol Mega university hospital in Turkey between May 2014 and June 2016, and comprised patients undergoing stem cell transplantation. They were divided into three groups. Group 1 had patients using chlorhexidine gluconate and benzydamine hydrochloride solution. Group 2 had those using calcium and phosphate solution. Group 3 patients were using black mulberry syrup. Data was collected using a structured questionnaire and the World Health Organisation mucositis assessment scale. Assessment was done on days 7, 14 and 21. Clinical significance of oral solutions was statistically determined. RESULTS: Of the 83 patients, 30(36%) were in group 1, 28(34%) in group 2, and 25(30%) in group 3. On day 7, there was no significant difference in terms of grades among the groups (p>0.05). On day 14, grade 2 mucositis was seen in 2(8%) patents in group 3, 5(17.9%) in group 2 and 5(16.7%) in group 1; Grade 3 mucositis was seen in 2(6.7%) patients in group 1, but none in the other two groups. On day 21, grade 3 mucositis was present in 2(8.0%) in group 3, 2(7.1%) in group 2, and 4(13.3%) in group 1. CONCLUSIONS: The use of black mulberry and calcium-phosphate solutions was found to be beneficial in preventing and treating oral mucositis.

Tantum verde mouthwash for tonsillectomy: A prospective, double-blind, randomized control trial.

OBJECTIVES: Post-tonsillectomy pain control is still considered a challenge. Topical agents would seem to be an ideal, safe option. Our objective was to compare the efficacy of mouthwash preparation with anti-inflammatory, anesthetic, and analgesic properties (Tantum Verde®, 0.15% benzydamine hydrochloride) with that of placebo in improving post-tonsillectomy morbidity. METHODS: A prospective, double blind, randomized clinical trial was performed. Patients older than 12-years-of-age who underwent tonsillectomy were recruited. Participants were randomized into 2 groups to receive either 0.15% benzydamine hydrochloride (TV) mouthwash solution (study arm) or a placebo solution. They were instructed to gargle the intervention they received 3 times a day for 7 days following surgery. Primary outcomes were intensity and duration of post-operative pain (using VAS visual analogue score) during a 2-week follow-up period. Secondary outcomes were pain medication demand, readmission, incidence of post-operative bleeding, hospital stay duration, and time to resume normal solid diet. RESULTS: Thirty-nine patients completed the study, of whom 23 received TV and 16 received placebo. The mean age was 23.1 years. There was no significant difference between the groups in the primary or secondary outcomes. CONCLUSIONS: The data suggest that topical treatment with TV mouthwash solution was not found to be superior to placebo in the management of post-tonsillectomy pain, bleeding, and return to a regular solid diet. Further research studies should be designed to investigate the ideal treatment for reducing post-tonsillectomy morbidity. CLINICAL TRIAL REGISTRATION: NIH identifier: NCT02190762; IRB NHR002814.

Oral flurbiprofen spray for postoperative sore throat and hoarseness: a prospective, randomized, double-blind, placebo-controlled study.

BACKGROUND: Sore throat and hoarseness are common complications after surgery. Flurbiprofen spray has been successfully used for treatment of oral inflammations, but its effects on postoperative sore throat and hoarseness are unknown. We conducted this study to evaluate the effectiveness of flurbiprofen spray on postoperative sore throat and hoarseness, by comparing it with benzydamine hydrochloride spray and placebo. METHODS: One hundred fifty patients who were scheduled to undergo elective ear surgery were enrolled. Patients were randomized to three groups of 50 patients each; flurbiprofen oral spray, benzydamine hydrochloride oral spray and placebo spray groups. Patients received sprays just before intubation, and the incidence and severity of postoperative sore throat and hoarseness were evaluated by a blinded investigator at 0, 1, 6 and 24-hour post extubation. Patients were also questioned for possible side effects at all time points. RESULTS: The sore throat severity scores were significantly lower in treatment groups when compared to placebo group at all time points (P=0.003/108). Similarly, the incidence of sore throat was significantly lower in both of the treatment groups (P=0.007/104). The incidence of hoarseness and hoarseness scores were significantly lower in treatment groups when compared to placebo group (P=0.006/105 and P=0.005/104, respectively). While none of the patients complained of any adverse effects in flurbiprofen group, only two patients in benzydamine hydrochloride group experienced numbness. CONCLUSIONS: Both oral flurbiprofen and benzydamine hydrochloride sprays were found to be more effective than placebo in decreasing the incidence and severity of postoperative sore throat and hoarseness, with no adverse effects.

Pharmacological modulation of radiation-induced oral mucosal complications.

Radiation-induced mucositis is a common toxicity, especially in patients with head and neck cancers. Despite recent technological advances in radiation therapy, such as intensity-modulated radiotherapy, radiation-induced mucositis is still causing treatment disruptions, negatively affecting patients' long and short term quality of life, and impacting medical resources use with economic consequences. The objective of this article was to review the latest updates in the management of radiation-induced mucositis, with a focus on pharmaceutical strategies for the prevention or treatment of mucositis. Although numerous studies analysing the prevention and management of oral radiation-induced mucositis have been conducted, there are still few reliable data to guide daily clinical practice. Furthermore, most of the tested drugs have shown no (anti-inflammatory cytokine, growth factors) or limited (palifermin) effect. Therapies for acute oral mucositis are predominantly focused on improving oral hygiene and providing symptoms control. Although low-level laser therapy proved efficient in preventing radiation-induced oral mucositis in patients with head and neck cancer, this intervention requires equipment and trained medical staff, and is therefore insufficiently developed in clinical routine. New effective pharmacological agents able to prevent or reverse radio-induced mucositis are required.