Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial.

BACKGROUND: This study aimed to evaluate the effect of oral glutamine suspension on salivary levels of transforming growth factor beta 1 (TGF-ß1), a cytokine involved in inflammation and Tumor progression, and the severity of radiation-induced oral mucositis (RIOM) in head and neck cancer patients. This is the first study to investigate the impact of glutamine on TGF-ß1 levels in head and neck cancer patients with radiation induced oral mucositis (RIOM). METHODS: In this randomized controlled clinical trial, 50 HNC patients were enrolled and received either glutamine oral suspension or maltodextrin as a placebo from the baseline of RIOM to the end of radiotherapy. Salivary TGF-ß1 levels were measured at baseline and after treatment. Also, RIOM was assessed using the World Health Organization (WHO) Oral Toxicity Scale, the Oral Mucositis Assessment Scale (OMAS), the Pain Visual Analog Scale (Pain-VAS), the incidence of opioid use, and body mass index (BMI). RESULTS: Glutamine significantly reduced salivary TGF-ß1 levels and improved RIOM symptoms, such as pain, opioid use, and weight loss. The reduction of TGF-ß1 levels was associated with the improvement of RIOM severity. CONCLUSION: Glutamine may modulate the inflammatory response and enhance wound healing in RIOM by decreasing salivary TGF-ß1 levels. These findings support the use of glutamine as a potential intervention for RIOM and nutritional support for improving radiation sensitivity. TRIAL REGISTRATION: This study was registered on clinicalTrials.gov with identifier no. NCT05856188.

Nurses' knowledge on assessment and management of cancer therapy-associated oral mucositis.

AIM: This study aimed to explore baseline nursing knowledge on assessment and management of patients at risk for developing cancer therapy-associated oral mucositis (OM) at a tertiary hospital in Ghana. DESIGN: A descriptive generic qualitative study design was conducted. The study population were nurses who cared for patients diagnosed with cancer. METHODS: Participants were recruited using a purposive non-probability sampling technique. Data were obtained through face-to-face interviews using semi-structured interview guide. Data collection and analysis were done concurrently. RESULTS: The study found that nurses had knowledge on the pre-treatment assessment of clients undergoing cancer treatment; however, they had insufficient knowledge on the standardized tool for the assessment of OM. They also lack a definitive approach to prevent and treat OM. Nurses provided general education on cancer treatment but paid little attention to the education on the possible side effect that includes OM. Additionally, insufficient knowledge level of nurses on cancer treatment-associated mucositis and lack of structured protocol for OM coupled with unavailable tools for assessing the oral mucosa were also identified as militating against the management of OM. Findings from this study will guide policy that will improve the care that clients who are at risk of oral mucositis receive.

Assessment of thyme honey oral gel for the prevention of adriamycin and cyclophosphamide chemotherapy-induced oral mucositis in patients with breast cancer.

PURPOSE: Oral mucositis (OM) is a common complication of cancer treatment that has an impact on a patient's quality of life and the outcome of cancer therapy. This trial evaluated the effect of thyme honey oral gel for the prevention of chemotherapy-induced OM. METHODS: One hundred ten breast cancer patients who received their first cycle of chemotherapy with adriamycin (60 mg/m2) and cyclophosphamide (600 mg/m2) were randomly recruited into two groups: group A were patients who followed general oral hygiene recommendations and rinsing saline 3 times a day, and group B were patients with similar protocol but supplied with our formulated oral gel to be applied 2 to 4 times a day. Patients were assessed by the World Health Organization (WHO) oral mucositis grading scales and self-assessment daily questionnaire. RESULTS: The use of thyme honey was associated with diminishing incidence of OM grade ≥ 2 (95% CI, 0.12 to 0.90; P = 0.030), duration of OM (- 3.36 days; 95% CI, - 5.50 to - 1.22; P = 0.037) and delayed occurrence of OM grade ≥ 2 (95% CI, 0.10 to 0.80; P = 0.017). CONCLUSION: Thyme honey can be considered as a prophylactic agent for OM and decrease the severity of its symptoms. TRIAL REGISTRATIONS: This protocol was registered at the Iranian Registry of Clinical Trials: registration number IRCT201506063106N25, on June 12, 2015; approved by the institutional review board at the Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran; and approved by the Ethics Committee of Medical Researches of Pharmaceutical Sciences Branch of Islamic Azad University, Tehran, Iran-reference number 5936, on August 17, 2014.

Efficacy Oral Glutamine to Prevent Oral Mucositis and Reduce Hospital Costs During Chemotherapy in Children with Acute Lymphoblastic Leukemia.

OBJECTIVE: To investigate the use of glutamine administered orally during Methotrexate chemotherapy to prevent oral mucositis and reduce hospital costs in children with acute lymphoblastic leukemia (ALL). METHODS: Twenty-four children received oral glutamine (400 mg/kg body weight per day) and twenty four received placebo on days of chemotherapy administration and for at least 14 additional days. Oral mucositis  was graded daily at each day of treatment till completion of therapy. The study groups were compared for the oral mucositis development using the WHO scale. RESULTS: Oral mucositis occurred in 4.2 % of the glutamine group and 62.5% in the placebo group. The use of glutamine was directly associated with prevention of oral mucositis than placebo (OR 0,026; 95% CI: 0,003-0,228). The duration of length hospital stay was lower in the glutamine group than in the placebo group ((8 vs 12 days); p = 0,005). Hospital cost per day for glutamine group was 40 USD per day while placebo group was 48 USD per day. CONCLUSIONS: There was significant difference in the prevention of oral mucositis by oral glutamine vs placebo. The hospital cost for glutamine supplementation was lower than control group.

Epidemiology, patient adherence, and costs of oral mucositis in routine care in stem cell transplantation.

PURPOSE: Limited data about oral mucositis (OM) in stem cell transplant patients with underlying hematological disease is available in Germany. The purpose of this feasibility study was to determine the incidence, treatment patterns, patients' adherence, and costs of OM. METHODS: Prospective, noninterventional single-center observational study. INCLUSION CRITERIA: allogenic/autologous stem cell transplant patients ≥ 18 years, high-dose chemotherapy. OM assessment: WHO Oral Toxicity Scale. Adherence was measured in patient interviews. Preventive and therapeutic measures were extracted from patients' charts. RESULTS: Forty-five patients (25 allogenic, 20 autologous) were enrolled. Twenty-six (58%) patients developed OM (54% grade I/II, 46% grade III/IV). Age ≥ 65 (31% vs 69%, p = 0.021) was associated with a lower OM incidence. A positive history of smoking (1.77 vs 2.69, p = 0.036) was associated with a lower OM grade, patients with unrelated donors (2.63 vs 1.29, p = 0.014) were associated with higher OM grades and females (80% vs 47%, RR = 1.71, p = 0.035) with a higher incidence. OM patients were less adherent to recommended daily mouth rinses (35% vs 68%, p = 0.027). More analgesic treatment (80% vs 32%, p = 0.001) and intravenous opioids (24% vs 0%, p = 0.023) were prescribed in OM patients. Total drug treatment and nutrition costs were 824€ (p = 0.037) higher in autologous transplanted patients. CONCLUSION: Initial risk and consecutive OM assessment, determination of patients' adherence, resource consumption, and costs are prerequisites to evaluate OM care. In the best case, several centers will follow the same methodological approach and the collected data will serve as a basis for benchmarking analyses to optimize OM care where required.

Assessment of indomethacin oral spray for the treatment of oropharyngeal mucositis-induced pain during anticancer therapy.

PURPOSE: The efficacy and safety of indomethacin (IM) oral spray (OS) as a pain control therapy for oropharyngeal mucositis due to anticancer chemo- and radiotherapy were assessed in patients with head and neck carcinomas and haematological tumours. METHOD: We observed 35 patients (male/female, 20/15; 53 ± 17 years) with oropharyngeal mucositis who were treated with IM-OS preparation for pain relief at University of Tsukuba Hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients. RESULTS: Pain relief was achieved in 26 (93%) patients at 25 (5-60) min after applying the IM-OS preparation (15.6 ± 3.4 µg/kg) and analgesic effects were maintained for 120 (10-360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 µg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray. CONCLUSIONS: The present IM spray is an effective and safe preparation for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancer patients.

Treatment for Cancer Patients with Oral Mucositis: Assessment Based on the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer in International Society of Oral Oncology (MASCC/ISOO) in 2013 and Proposal of Possible Novel Treatment with a Japanese Herbal Medicine.

The cancer patients who received chemotherapy, radiotherapy, hematopoietic stem cell transplant and terminal care often have a wide range of stomatitis, which induces severe pain and limits fundamental life behaviors such as "eating, drinking and talking". In addition, oral mucositis frequently leads to systemic infection through opportunistic microorganisms, which causes extension of hospitalization. Severe oral mucositis often causes cancer patients to partially or completely discontinue/modify cancer therapy regimen, which adversely affects the curative effects of cancer. Therefore, the control of oral mucositis is important and indispensable for improvement of quality of life and prognosis. In this review, we introduce recent trends of the oral mucositis management in cancer patients, according to the following sentences; 1) pathophysiological mechanisms of oral mucositis, 2) assessment, 3) risk factors, 4) prevention and treatment, and 5) development of novel therapy for oral mucositis.

Comparative assessment of the therapeutic effects of the topical and systemic forms of Hypericum perforatum extract on induced oral mucositis in golden hamsters.

Oral mucositis is a common and irritating complication of chemotherapy and radiotherapy for malignancies. Current treatments have failed to achieve complete remission of this complication. The St. John's wort plant (Hypericum perforatum) has long been known for its anti-inflammatory and antibacterial effects. The current study was designed to investigate the therapeutic efficacy of the topical and systemic administration of H. perforatum extract on oral mucositis. Oral mucositis was induced in 72 male golden hamsters by administration of 5-fluorouracil (60mg/kg), on days 0, 5, and 10 of the study. The cheek pouch was scratched with a sterile needle on days 1 and 2. On days 12-17, H. perforatum extract topical gel 10%, oral H. perforatum extract (300mg/kg), and gel base groups were treated and then compared with a control group. Weights and blood samples were evaluated, biopsies from buccal lesions were examined histopathologically, and tissue malondialdehyde (MDA) was measured. Both of the H. perforatum extract treatment groups saw a significant relief in oral mucositis compared to the control and base gel groups; the systemic form was superior to the topical form. H. perforatum extract, administered orally or topically, expedited the healing of chemotherapy-induced oral mucositis in hamsters.

Impact of palifermin on incidence of oral mucositis and healthcare utilization in children undergoing autologous hematopoietic stem cell transplantation for malignant diseases.

Palifermin has been demonstrated to decrease the incidence of severe oral mucositis in adults following TBI containing conditioning regimens prior to AHSCT. The impact of palifermin on the incidence of oral mucositis in children undergoing AHSCT has never been studied. We compared the effect of palifermin on the incidence of oral mucositis and supportive care in 58 children undergoing myeloablative AHSCT; 25 children received palifermin and 33 children did not receive palifermin (control arm). Oral mucositis was graded as per WHO criteria. The demographic characteristics were comparable between the two arms. Results comparing the palifermin vs. control arm showed that the incidence of grade III-IV oral mucositis was 20% vs. 42.4% (p = 0.072). The number of days patients received patient-controlled analgesia and total parenteral nutrition in the palifermin vs. control arm were 8.80 ± 8.39 vs. 8.30 ± 8.54 (p = 0.826) and 13.52 ± 11.32 vs. 11.55 ± 9.63 (p = 0.484), respectively. The average length of hospitalization in the palifermin vs. control arm was 31.44 ± 7.42 vs. 28.61 ± 10.38 (p = 0.252), respectively. In this study, we were unable to demonstrate a statistical difference in the incidence of oral mucositis and other supportive care needs or a decrease in hospital stay between the two arms.

Assessment of the effect of local application of amifostine on acute radiation-induced oral mucositis in guinea pigs.

The aim of present study was to assess the radioprotective effects of the local application of amifostine to treat acute buccal mucositis in guinea pigs. A total of 32 guinea pigs were randomized into four groups: (Group A) topically administered 50 mg of amifostine plus radiotherapy (RT); (Group B) 100 mg amifostine plus RT; (Group C) normal saline plus RT; and (Group D) normal saline plus sham RT. The opportunity for administration was 15 min before irradiation. When administered, the cotton pieces that had been soaked with 0.5 ml amifostine solution or saline were applied gently on the buccal mucosa of each guinea pig for 30 min. The animals in Groups A, B and C were irradiated individually with a single dose of 30 Gy to the bilateral buccal mucosa. Eight days after irradiation, the animals were scored macroscopically; they were then euthanized, and the buccal mucosal tissues were processed for hematoxylin-eosin staining and ICAM-1 immunohistochemical analysis. In Groups A and B, the mean macroscopic scores were 2.9 ± 0.6 and 2.4 ± 1.1, respectively. There was no significant difference between the two groups (P > 0.05). However, when they were separately compared with Group C (4.4 ± 0.7), a noticeable difference was obtained (P < 0.05). No mucositis was observed in Group D. Comparisons of the expression of ICAM-1 were in agreement with the macroscopic data. Histologically, superficial erosion, exudate and ulcer formation were all observed in the RT groups; only the severity and extent were different. The microscopic observations in the amifostine-treated groups were better than in Group C. The results demonstrated that topical administration of amifostine to the oral mucosa is effective treatment of acute radiation-induced mucositis.

Oral mucositis: etiology, and clinical and pharmaceutical management.

Oral mucosal damage is one of the common and worst side effects of radiotherapy and chemotherapy treatment for cancer. With prevalence between 10% and 100%, depending on the cytotoxic and/or radiotherapy regimen and patient-associated variables, this morbid condition represents a significant problem in oncology. This article addresses oral mucositis and discusses its prevalence, risk factors, clinical and economical impacts, etiology, and clinical management in view of the most recent evidence. Despite clear progress and the development of clinical guidelines on this topic, what we currently have to offer to patients to manage mucositis and oropharyngeal pain is still inadequate. This article offers two compounded preparations supported by evidence-based data to treat oral mucositis. Expansion of the knowledge of the pathogenesis of mucositis as well as a better insight into individual risk factors will provide opportunities to improve management strategies.

Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life.

BACKGROUND: The risk, severity, and patient-reported outcomes of radiation-induced mucositis among head and neck cancer patients were prospectively estimated. METHODS: A validated, patient-reported questionnaire (OMDQ), the FACT quality of life (QOL), and the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scales were used to measure mucositis (reported as mouth and throat soreness), daily functioning, and use of analgesics. Patients were studied before radiotherapy (RT), daily during RT, and for 4 weeks after RT. RESULTS: Contrary to previous reports, the risk of mucositis was virtually identical in the 126 patients with oral cavity or oropharynx tumors (99% overall; 85% grade 3-4) compared with 65 patients with tumors of the larynx or hypopharynx (98% overall; 77% grade 3-4). The mean QOL score decreased significantly during RT, from 85.1 at baseline to 69.0 at Week 6, corresponding with the peak of mucositis severity. The mean functional status score decreased by 33% from 18.3 at baseline to 12.3 at Week 6. The impact of mucositis on QOL was proportional to its severity, although even a score of 1 or 2 (mild or moderate) was associated with a significant reduction in QOL (from 93.6 at baseline to 74.7 at Week 6). Despite increases in analgesic use from 34% at baseline to 80% at Week 6, mean mucositis scores exceeded 2.5 at Week 6. CONCLUSIONS: Mucositis occurs among virtually all patients who are undergoing radiation treatment of head and neck cancers. The detrimental effects on QOL and functional status are significant, and opioid analgesia provides inadequate relief. Preventive rather than symptom palliation measures are needed.

Validation of the oral mucositis assessment scale in pediatric cancer.

BACKGROUND: Our objective was to examine the construct validity of the Oral Mucositis Assessment Scale (OMAS) in children receiving doxorubicin chemotherapy. METHODS: Children between 6 and 18 years of age with cancer receiving doxorubicin-containing chemotherapy were included. OMAS was measured on days 7, 10, 14, and 17 after chemotherapy. Other measures of mucositis obtained concurrent with OMAS were the World Health Organization (WHO) mucositis scale and pain visual analogue scale (VAS). We also recorded analgesia administration. RESULTS: Sixteen children were studied for 45 post-chemotherapy cycles and 156 OMAS assessments were performed. OMAS was moderately correlated with WHO scores (r = 0.56; P = 0.0006) whereas correlation with the pain VAS was fair (r = 0.37; P = 0.002). OMAS also had fair correlation with the number of doses of topical analgesia (r = 0.43; P = 0.001) and with the cumulative dose of opioid analgesia (r = 0.38; P = 0.003). CONCLUSIONS: The OMAS is valid for use in mucositis clinical trials for children at least 6 years of age.

Pharmacokinetics, pharmacodynamics, and safety assessment of palifermin (rHuKGF) in healthy volunteers.

BACKGROUND: Palifermin is a recombinant human keratinocyte growth factor approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies who received myelotoxic therapy requiring hematopoietic stem cell support. METHODS: This randomized, double-blind, placebo-controlled study investigated the pharmacokinetics, pharmacodynamics, and safety of palifermin in healthy volunteers after single, escalating doses (60 to 250 mug/kg). Pharmacodynamic measurements (Ki67 staining) assessing buccal mucosal epithelial proliferation were performed at baseline and at 48 or 72 hours after dosing. RESULTS: Exposure to palifermin increased approximately dose proportionally, with a 3-fold increase observed for a 4-fold increase in dose. Palifermin concentrations decreased sharply during the first 0.5 to 1.5 hours after dosing, slightly increased or plateaued between 1.5 and 6 hours, and subsequently decreased. The overall mean systemic clearance and volume of distribution at steady state were 590 mL/h/kg and 2000 mL/kg, respectively. The mean half-life ranged from 4.5 to 6 hours across the dose levels. The mean and SD ratio of Ki67 staining at 48 hours after dosing to baseline was 1.19 (0.24) for placebo, 2.02 (0.60) for 60 mug/kg, 3.04 (1.13) for 120 mug/kg, and 4.66 (0.77) for 250 mug/kg-treated groups. CONCLUSION: Palifermin exhibited linear pharmacokinetics and caused dose-dependent epithelial proliferation.

Anti-inflammatory agents in the management of alimentary mucositis.

BACKGROUND: Alimentary mucositis is a significant complication of cancer therapy, with important clinical and economic implications. MATERIALS AND METHODS: In June 2005, the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology conducted an evidence-based review of the literature on alimentary mucositis. The goal of this literature review was to update previously published guidelines for the management of mucositis. RESULTS: This article reports the findings of the subgroup charged with reviewing the literature related to anti-inflammatory interventions. Considerable preclinical and clinical evidence suggests that the use of anti-inflammatory agents may be a promising approach to reduce the severity of mucositis. However, there was not enough evidence to support any new guidelines advocating the use of any specific anti-inflammatory intervention. CONCLUSION: Thus, there is a need for well-designed clinical trials evaluating the use of anti-inflammatory agents in the management of mucositis.

Iseganan (IntraBiotics pharmaceuticals).

Iseganan (IB-367) is a protegrin under development by IntraBiotics, as part of a larger protegrin program, for the potential treatment of oral mucositis, a frequent side effect of anticancer therapies. The company is developing three formulations of the drug: A rinse for the potential treatment of mucositis, an aerosolized liquid for the potential treatment of respiratory infection and a gel formulation for the potential treatment of pneumonia [376325]. Iseganan kills a broad-spectrum of bacteria and fungi, including those resistant to conventional antimicrobial drugs, by attaching to and destroying the integrity of the lipid cell membrane [241594]. Until August 1999, Pharmacia & Upjohn was a codeveloper of iseganan. IntraBiotics re-acquired the global rights to iseganan in December 1999, and both companies agreed to terminate the collaboration [335766]. In May 2000, analysts at SG Cowen predicted the drug's potential market at US $100 to US $200 million [376325].

A pilot study evaluating the safety and microbiologic efficacy of an economically viable antimicrobial lozenge in patients with head and neck cancer receiving radiation therapy.

BACKGROUND: Mucositis occurs in almost all radiotherapy-treated head and neck cancer patients, in approximately 75% of patients receiving hematopoietic marrow transplantation, and in approximately 40% of all patients who receive chemotherapy. Mucositis is painful, may affect all oral functions, and is a dose- and rate-limiting toxicity of therapy for cancer. Radiation-associated mucositis (onset, intensity, and duration) has been shown in recent clinical trials to be modified by the use of antibacterial/antifungal lozenges. PURPOSE: The aim of this collaborative two-center phase II study was to assess the toxicity and microbiologic efficacy of an economically viable antimicrobial lozenge in the management of patients receiving radiation therapy for head and neck cancer. MATERIALS AND METHODS: Seventeen patients scheduled to receive radical or postoperative radiotherapy were provided with bacitracin, clotrimazole, and gentamicin (BCoG) lozenges (one lozenge dissolved in the mouth qid from day 1 of radiotherapy until completion). Ease of use and palatability of the lozenges, patients' symptoms (swallowing and pain), and quantitative and qualitative microbiologic evaluation of an oral rinse collection was conducted at least once weekly during radiation therapy. RESULTS: No significant side effects were reported from the use of the lozenges. The lozenges were well tolerated at the beginning of treatment by all patients, with some minor difficulty associated with oral discomfort toward the end of the treatment. Microbiologic evaluation showed consistent elimination of yeast organisms in all patients. In four patients there was no growth of gram-negative bacilli on culture, whereas in two patients, fluctuating counts were seen, and one patient had increased counts. The remaining patients had significant reduction in the gram-negative bacilli counts. CONCLUSIONS: This study demonstrated that the BCoG lozenge is tolerable and microbiologically efficacious, achieving elimination of Candida in all patients and reduction in gram-negative flora in most patients. A phase III study is underway to evaluate the clinical efficacy of this lozenge.

New frontiers in the management of chemotherapy-induced mucositis.

About one-third of patients undergoing chemotherapy treatment suffer oral mucositis, an inflammatory-like change of the oral mucosa. Severe pseudomembranous/ulcerative mucositis can lead to secondary infection of lesions, sepsis and even cessation of treatment. Patients receiving curative head-neck irradiation are most susceptible and children undergoing chemotherapy are three times more likely to be affected. Mucositis is a costly side-effect of cancer therapy due to the extra time patients spend in hospital and currently there is no consistently effective treatment. Experimental studies with TGF-beta 3, a potent negative regulator of epithelial and haematopoietic stem cell growth, have shown that it is possible to temporarily arrest oral mucosal basal cell proliferation, and could therefore offer a new effective and safe form of preventative intervention for patients about to undergo aggressive regimens of cancer therapy.

Evaluating cost-effectiveness in outpatient management of medical complications in cancer patients.

It has been estimated that 85% to 90% of all cancer patient care occurs in the outpatient setting, and the vast majority of chemotherapy is administered in the outpatient setting either in physician offices or hospital clinics. With the introduction of white blood cell growth factors in the early 1990s, dose-intensive regimens either for curative or palliative therapy became more common. Since that time, major dose-limiting toxicities have become gastrointestinal mucositis and chemotherapy-induced thrombocytopenia. Patient-reported symptoms have also become important as the changing financing and reimbursement for health care shifts the focus to a patient-centered, value-oriented approach in hematology and medical oncology. This paper will examine advances in the management of three common complications of antineoplastic therapy, mucositis, thrombocytopenia, and fatigue, with a particular emphasis on cost-effectiveness as it relates to value in health care.

[Evaluation of benzydamine in treatment of secondary inflammation following extraction of third molars]. / Valoración de bencidamina en el tratamiento de la inflamación secundaria después de la extracción de terceros molares.

A comparative, double-blind, observant, prospective and longitudinal study was performed over 27 patients treated at the maxillofacial surgery unit of the "Adolfo López Mateos" General Hospital, ISSSTE, for the purpose of evaluating the efficacy and tolerability of benzydamine oral spray in post-extraction inflammation. Patients of either sex and assorted ages were selected, with a prerequisite of no current pathology or previous history of hipersensibility. They were divided in two groups, the first one receiving a placebo, and 1.5% oral benzydamine spray applied to the second group. Each patient was instructed to apply the medication six times per day (with four sprays per application) for five days, and clinically evaluated before the study and after two and after five days of treatment. Female patients were predominant, and ages averaged 30.9 years in the benzydamine group and 28.4 years in the lot receiving placebo. Clinical and laboratory evaluations were performed after treatment, with superior results as to clinical course observed in the group treated with benzydamine, as compared to the placebo lot. Usefulness of benzydamine spray in the postop treatment of dental trauma (i.e., extraction of third molars), as well is its antiseptic and analgesic properties, were objectively verified in the patients.