New Cooling Device for Oral Mucosa Better Tolerated and Equally Effective As Ice Cooling

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5806-5806
Author(s):  
Java Walladbegi ◽  
Anncarin Svanberg ◽  
Gunnar Birgegard ◽  
Mats Jontell
Keyword(s):  
Healthy Volunteers ◽  
Oral Mucosa ◽  
Oral Mucositis ◽  
Buccal Mucosa ◽  
Research Funding ◽  
Poor Quality ◽  
Cooling Device ◽  
Circulating Water ◽  
Temperature Reduction ◽  
Thermographic Camera

Abstract Introduction: Oral mucositis (OM) is an inflammation of the oral mucosa affecting up to 80% of all patients receiving myeloablative therapy prior to stem cell transplantation. The complication manifests as ulcerations and may require high doses of morphine for pain alleviation.OM may also interfere with food intakeand result in parenteral nutrition, weight loss and impaired quality of life. Current literature indicates very few evidence-based interventions for prevention of OM. Cryotherapy (CT),using ice chips has reported to efficiently reduced grade and extent of OM, although clinical use is still limited due to several disadvantages. These include adverse teeth sensations, nausea and uneven cooling of the oral mucosa. Moreovercontinuous supply of ice chips is needed during treatment sessions and thewater from which ice chips are made may be of poor quality, leading to health hazards. Objectives: The primary endpoint of the present study was to evaluate the tolerability of an intraoral cooling device (Cooral) compared with ice chips. Secondary endpoints were temperature reduction and cooling distribution. Methods:To avoid the adverse effects and reduce the disadvantages of ice chips an optimal fitting mouth-cooling device (Fig. 1), shaped and dimensioned to cool the gums, cheeks, tongue, palate and base of the mouth was designed. Thecooling device is made of a closed channel system with continuous circulating water and has the advantage over ice chips as the water temperature can be adjusted. 20 healthy volunteers (mean age: 24 years) (17 women; 3 men) were enrolled in this cross over study. Each individual used the cooling device and ice chips for 60 minutes in two separate sessions with at least 24 hours apart. Prior to inclusion, the procedure was explained in writing and a written informed consent was obtained. Baseline- and final temperatures were measured (Fig. 2) in eight intraoral locations (right buccal mucosa, left buccal mucosa, upper labial mucosa, lower labial mucosa, anterior and posterior dorsal tongue, ventral tongue and hard palate) using an infrared thermographic camera (FLIR-60). Following each cooling session a questionnaire, specifically developed for the study to assess tolerability, was completed. In total 700 thermographic images were analysed using FlIR-60 tools software and BioPix. Results: The cooling device was found to be significantly better tolerated compared to ice chips and was preferred by 16 out of 20 participants (P=0.0118; Fig. 3). Three individuals preferred ice chips as they were frequently habitually chewing on ice. One individual reported that the device was experienced as too big, a problem that will be solved in the future, as three different sizes of the device will be produced. Finally, the device was found to be as efficient as ice chips in terms of cooling reduction and cooling distribution. Conclusions: The cooling device was significantly better tolerated and provided as efficient temperature reduction and cooling distribution as ice chips in healthy volunteers. The device has the potential not just to improve the comfort but in the long term also optimize the effect of cryotherapy with the aim of preventing oral mucositis. The next step in this research will be to evaluate the cooling device in a clinical setting to establish its tolerability and efficacy of preventing oral mucositis. FormulŠrets nederkant Disclosures Walladbegi: BraincCool: Employment, Research Funding. Svanberg:BrainCool: Employment, Research Funding. Jontell:BrainCool: Research Funding.

scholarly journals Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers

2020 ◽  
Vol 37 (12) ◽  
Author(s):  
C. Blacker ◽  
T. Kamsvåg ◽  
R. S. Bejhed ◽  
G. Ljungman
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
Oral Mucosa ◽  
Oral Mucositis ◽  
Randomized Clinical Trials ◽  
Common Side Effect ◽  
Air Cooling ◽  
Temperature Reduction ◽  
Oral Cryotherapy

AbstractOral mucositis is a common side effect of chemo and radiotherapy causing painful ulcers in the oral mucosa. One of the preventive treatments recommended in international guidelines is oral cryotherapy (OC). Randomized clinical trials on OC have used ice and ice-chips to cool the mouth, but this cooling method can be difficult for the patients to tolerate. Studies have shown that OC with ice for a period of 60 min reduces the oral temperature by 12.9 °C. The aim of this pilot study was to evaluate the temperature reduction and tolerability of OC using an intra-oral air-cooling (IOAC) device in healthy volunteers. Twelve healthy volunteers, mean age 35.4 years, were included in the study. They were treated with OC using the IOAC device for 60 min. Measurements of temperature were obtained at baseline, 5 and 60 min using a FLIR® C2 camera. After the OC session, tolerability and adverse events were documented using a questionnaire. All participants were able to use the device for 60 min. The overall temperature reduction after 5 min of OC was 10.7°C (p < 0.01) and after 60 min 14.5°C (p < 0.01). The most common adverse events were bad fit of the mouthpiece (n = 6), hypersalivation (n = 6), and difficulties swallowing (n = 5). The oral device reduced the temperature of the oral mucosa as much as treatment with ice with tolerable adverse events. The mouthpiece will be remodeled to improve tolerability before further studies are conducted.

scholarly journals Effectiveness of a Central Discharge Element Sock for Plantar Temperature Reduction and Improving Comfort

2021 ◽  
Vol 18 (11) ◽  
pp. 6011
Author(s):  
Alfonso Martínez-Nova ◽  
Víctor Manuel Jiménez-Cano ◽  
Juan Miguel Caracuel-López ◽  
Beatriz Gómez-Martín ◽  
Elena Escamilla-Martínez ◽  
...  
Keyword(s):  
Temperature Increase ◽  
Likert Scale ◽  
Contact Zones ◽  
Temperature Reduction ◽  
Thermographic Camera ◽  
Design Weight

U-shaped plantar cushions could help reduce stress affecting the central forefoot without the need for an orthosis, but they are yet to be integrated as an element in socks. The objective of this study was to verify the effectiveness of a sock with a central discharge element in terms of plantar temperature and comfort. The sample comprised 38 subjects (13 men and 25 women). Their plantar temperatures were measured with a thermographic camera in a basal situation and after each of two 10-minute walks around an indoor circuit during which they wore either control or experimental socks at random (the same design, weight, and fiber, but with the plantar cushioning element added). After the walks, each subject responded to a comfort questionnaire (five-point Likert scale), blindly scoring the two socks. The highest temperatures (28.3 ± 2.7 °C) were recorded in the zone of the second and third metatarsal heads. With the experimental socks, the observed temperature increase in the central forefoot zone was significantly less than with the control socks (31.6 vs 30.6 °C, p = 0.001). The subjects found the experimental socks to be more comfortable than the controls (4.63 ± 0.5 vs 4.03 ± 0.5, p < 0.001). The discharge element included in the experimental socks was effective since it reduced the contact zones and excess friction with the ground, thereby lessening overheating by more than 1°C. Furthermore, the experimental socks were perceived as being more comfortable by the subjects who had mild and occasional foot discomfort.

scholarly journals Candida albicans in patients with oronasal communication and obturator prostheses

2009 ◽  
Vol 20 (4) ◽  
pp. 336-340 ◽  
Author(s):  
Beatriz Silva Câmara Mattos ◽  
Andréa Alves de Sousa ◽  
Marina Helena C. G. de Magalhães ◽  
Marcia André ◽  
Reinaldo Brito e Dias
Keyword(s):  
Candida Albicans ◽  
Oral Mucosa ◽  
Sodium Hypochlorite ◽  
Buccal Mucosa ◽  
Treatment Evaluation ◽  
Antifungal Treatment ◽  
Therapeutic Protocol ◽  
Candidal Infection ◽  
Oral Candida ◽  
Palatal Mucosa

Patients using obturator prostheses often present denture-induced stomatitis. In order to detect the presence of oral Candida albicans in patients with oronasal communications and to evaluate the effectiveness of a topical antifungal treatment, cytological smears obtained from the buccal and palatal mucosa of 10 adult patients, and from the nasal acrylic surface of their obturator prostheses were examined. A therapeutic protocol comprising the use of oral nystatin (Mycostatin®) and prosthesis disinfection with sodium hypochlorite was prescribed for all patients. Seven patients were positive for C. albicans in the mucosa, with 1 negative result for the prosthetic surface in this group of patients. Post-treatment evaluation revealed the absence of C. albicans on prosthesis surface and on the oral mucosa of all patients. The severity of the candidal infection was significantly higher in the palatal mucosa than in the buccal mucosa, but similar in the palatal mucosa and prosthesis surface, indicating that the mucosa underlying the prosthesis is more susceptible to infection. The therapeutic protocol was effective in all cases, which emphasizes the need for denture disinfection in order to avoid reinfection of the mucosa.

scholarly journals Prevalence of Oral Mucosal Lesions in a Tertiary Care Dental Hospital of Kathmandu

2017 ◽  
Vol 56 (207) ◽  
pp. 362-366
Author(s):  
Dipshikha Bajracharya ◽  
Sujaya Gupta ◽  
Bidhata Ojha ◽  
Radha Baral
Keyword(s):  
Squamous Cell Carcinoma ◽  
Retrospective Study ◽  
Oral Cavity ◽  
Cell Carcinoma ◽  
Oral Mucosa ◽  
Buccal Mucosa ◽  
Tertiary Care ◽  
Oral Mucosal Lesions ◽  
Dental Hospital ◽  
Mucosal Lesions

Introduction: Oral mucosa can be affected by a variety of soft tissue lesions and conditions. Benign as well as malignant lesions of oral cavity are common. Squamous cell carcinoma is one of the commonest malignancies. The present retrospective study was undertaken to study the prevalence of various oral mucosal lesions in a tertiary care dental hospital of Kathmandu. Methods: This retrospective study was carried out in the Department of Oral and Maxillofacial Pathology at Kantipur Dental College and Teaching hospital from January 2015 to January 2017. The study included biopsy specimen from the oral cavity. The parameters included in the study were age, gender, site of the lesion and histopathological diagnosis. The data collected was statistically analyzed. Results: A total of 111 biopsy cases were included in the present study. Out of which, there was 16 (14.4%) cases of non neoplastic and 16 (14.4%) cases of benign pathology. The oral cavity lesions were commonly seen in age range between 6-74 years where males 59 (53.2%) were mostly affected. The most common site for oral lesion was buccal mucosa 23 (20.7%) and anterior gingiva 23 (20.7%). 15 (13.5%) cases of oral squamous cell carcinoma were seen as the predominant malignancy affecting in the vestibular region 8 (7.2%). Conclusions: The present study shows benign as well as the non neoplastic lesions were more prevalent in oral mucosa with the buccal mucosa and anterior gingiva as the commonest site of occurrence. Keywords: Benign; Malignant; Non neoplastic; Oral mucosal lesion.

scholarly journals Formulation Development of Mucoadhesive Microparticle-Laden Gels for Oral Mucositis: An In Vitro and In Vivo Study

Pharmaceutics ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 603
Author(s):  
Hiroomi Sakurai ◽  
Yuri Ikeuchi-Takahashi ◽  
Ayaka Kobayashi ◽  
Nobuyoshi Yoshimura ◽  
Chizuko Ishihara ◽  
...  
Keyword(s):  
Oral Mucosa ◽  
Oral Mucositis ◽  
Formulation Development ◽  
Scanning Calorimetry ◽  
In Vivo Experiments ◽  
Drug Retention ◽  
Drug Concentrations ◽  
Diffraction Patterns

In order to relieve pain due to oral mucositis, we attempted to develop mucoadhesive microparticles containing indomethacin (IM) and gel preparations with IM microparticles that can be applied to the oral cavity. The mucoadhesive microparticles were prepared with a simple composition consisting of IM and polyvinyl alcohol (PVA). Two kinds of PVA with different block properties were used, and microparticles were prepared by heating-filtration and mixing-drying. From the X-ray powder diffraction patterns, differential scanning calorimetry thermograms, and morphological features of the IM microparticles, IM should exist as polymorphic forms in the microparticles. Rapid drug release properties were observed in the IM microparticles. Increased drug retention was observed in IM microparticles containing PVA, and the IM-NK(50) gel, using a common block character PVA and heating-filtration, showed good long-term drug retention properties. In vivo experiments showing significantly higher drug concentrations in the oral mucosa were observed with IM microparticles prepared by heating-filtration, and the IM-NK(50) gel maintained significantly higher drug concentrations in the oral mucosa. From these results, the IM-NK(50) gel may be useful as a preparation for relieving oral mucositis pain.

scholarly journals Familial oral lichen planus in a 3-year-old boy: a case report with eight years of follow-up

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Fang Wang ◽  
Ya-Qin Tan ◽  
Jing Zhang ◽  
Gang Zhou
Keyword(s):  
Lichen Planus ◽  
Oral Mucosa ◽  
Buccal Mucosa ◽  
Oral Lichen Planus ◽  
Familial Aggregation ◽  
Pediatric Population ◽  
Case Presentation ◽  
Oral Lichen

Abstract Background Oral lichen planus (OLP) is a chronic mucocutaneous disease characterized by adult predominance and a prolonged course. However, it is rare in the pediatric population with familial aggregation. Case presentation A 3-year-old boy presented with pain and irritation on the oral mucosa while contacting spicy food for 2 months. Oral examination showed widespread whitish reticular and papular lesions on the lips, the dorsum of the tongue, and bilateral buccal mucosa, with diffuse erosions covered with pseudomembrane on the buccal mucosa. The boy’s parents were examined to exhibit white reticular and plaque-like lesions on their oral mucosa. The three patients were clinically diagnosed as affected by OLP and histopathologically confirmed. The boy underwent topical treatment with recombinant bovine basic fibroblast growth factor (rb-bFGF) gel, and oral lesions gradually resolved and healed. Neither of his parents received treatment. During the subsequent follow-ups, none of three patients underwent any medical treatment. Fortunately, their lesions had almost faded over 8 years. Conclusions Our case emphasizes that pediatric OLP should be recorded with family history. Besides, long-term periodic follow-up is recommended in pediatric patients with OLP for monitoring any changes in lesions.

Relationship between buccal mucosa ridging and viscoelastic behaviour of oral mucosa

2010 ◽  
Vol 38 (6) ◽  
pp. 429-433 ◽  
Author(s):  
S. KUMAKURA ◽  
K. SAKURAI ◽  
Y. TAHARA ◽  
K. NAKAGAWA
Keyword(s):  
Oral Mucosa ◽  
Buccal Mucosa ◽  
Viscoelastic Behaviour

A Rare Genetic Polymorphism In C5 Confers Poor Response To The Anti-C5 Monoclonal Antibody Eculizumab In 11 Japanese Patients With PNH

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3709-3709
Author(s):  
Jun-ichi Nishimura ◽  
Masaki Yamamoto ◽  
Shin Hayashi ◽  
Kazuma Ohyashiki ◽  
Kiyoshi Ando ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Hemolytic Activity ◽  
Research Funding ◽  
Poor Response ◽  
Heterozygous Mutation ◽  
Poor Responders ◽  
Classical Pathway ◽  
Employment Equity ◽  
Equity Ownership

Abstract Eculizumab is a humanized monoclonal antibody targeting the terminal complement protein C5 and inhibiting terminal complement-mediated hemolysis associated with paroxysmal nocturnal hemoglobinuria (PNH). In the Japanese AEGIS PNH-eculizumab study, 2 poor-responders were identified out of 29 cases. Currently, more than 300 patients have been treated with eculizumab, and a total of 11 poor-responders were identified all of whom are Japanese. To clarify the mechanism of difference in the responsiveness of eculizumab, blood samples from poor and good responders were analyzed after obtaining informed consent. Approval for these studies was obtained from the institutional review boards at each study site taking care of patients as well as from Osaka University. The levels of lactate dehydrogenase in these two patients were markedly elevated before eculizumab treatment, and were not decreased during the 12 weeks AEGIS study. From the pharmacokinetic analysis, peak and trough levels of eculizumab during the study were well above the minimal level required to completely inhibit complement-mediated hemolysis in PNH patients. The pharmacodynamics of eculizumab were determined by measuring the capacity of the patients’ serum to lyse chicken erythrocytes in a standard hemolytic assay. Serum samples analysed from these two patients failed over the entire treatment period, to show a suppression of hemolysis, prompting further study of the effect of exogenous eculizumab on the hemolytic activity of patient pre-drug sera. Eculizumab up to 2000μg/mL did not block hemolytic activity in the sera of either poor-responder. However, hemolytic activity both in the two poor-responders and in control patient was blocked completely using a different anti-C5 antibody (N19/8) at 50μg/mL. Therefore, the DNA of C5 from Japanese PNH patients with a good or poor response to eculizumab was sequenced, and a single missense C5 heterozygous mutation at exon 21, c.2654G>A, which predicts p.Arg885His, was found in all of the 11 poor responders identified to date, but not in any of the responders. Among about 300 Japanese patients treated with eculizumab, 11 patients (about 3.7%) have been identified as poor responders. A similar prevalence (3.5%) was seen in healthy volunteers, since we determined that 10 out of 288 Japanese healthy volunteers have the same mutation. This polymorphism was also identified in 1 out of 120 China Han healthy volunteers, but not in 100 persons of British ancestry living in England and Scotland, and not in 90 persons of Mexican ancestry in Los Angels. To close the genotype-phenotype loop, electrophoretically pure recombinant C5 (rC5) and rC5 mutant (rC5m) containing c.2654G>A were generated and functionally compared in various in vitro experiments. As a preliminary experiment, we confirmed that natural C5, rC5, and rC5m restored classical pathway lysis equivalently when added to C5-depleted serum. Eculizumab did not block classical pathway lysis reconstituted with rC5m but did block rC5 and nC5-dependent lysis. By contrast, as observed with patient sera, N19/8 inhibited lysis reconstituted with nC5, rC5, and rC5m. Finally, while eculizumab bound nanomolar concentrations of rC5 using surface plasmon resonance, with clear association and dissociation phases, there was no detectable binding with rC5m in the same assay up to the highest concentration (1 µM) of eculizumab examined. A single missense C5 heterozygous mutation, c.2654G>A, which predicts p.Arg885His, was commonly identified in poor-responders, but not in responders. This polymorphism had at least spread to other East Asian countries. After determining that the poor responders likely express both wild-type C5 and a structural variant C5, we then showed that the hemolytic activity supported by this structural variant in vitro, like the effects on patient sera, was not blocked by eculizumab but was fully blocked by N19/8, and that the variant was incapable of binding eculizumab. Collectively, these data are consistent with the hypothesis that the functional capacity of the mutant C5 together with its inability to bind to and undergo blockade by eculizumab fully account for the poor response in patients carrying this mutation. (JN and MY contributed equally to this work) Disclosures: Nishimura: Alexion Pharmaceuticals, Inc.: Research Funding, Speakers Bureau. Yamamoto:Alexion Pharm: Research Funding. Ohyashiki:Alexion: Research Funding. Noji:Alexion Pharmaceuticals: Honoraria. Shichishima:Alexion Pharmaceuticals: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Hase:Alexion Phama: Employment, Equity Ownership. Lan:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership. Johnson:Alexion Pharmaceuticals, Inc.: Employment. Tamburini:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership, Patent inventor but do not receive royalties, Patent inventor but do not receive royalties Patents & Royalties. Kinoshita:Alexion: Honoraria. Kanakura:Alexion Pharmaceuticals: Research Funding, Speakers Bureau.

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