Feasibility and efficacy of endoscopic purse-string suture-assisted closure for mucosal defects induced by endoscopic manipulations

BACKGROUND Large or transmural defects induced by gastrointestinal endoscopic manipulations are difficult to close,although complete closure is recommended for better recovery.Endoscopic purse-string assisted suturing(EPSS)has been used in clinical practice and has proven to be an effective and safe technique for the closure of large mucosal defects.However,details regarding the efficacy of endoscopic pre-purse-string suture(P-EPSS)are unknown,especially that it offers several advantages over conventional EPSS(C-EPSS).AIM To elucidate the outcomes of EPSS-assisted closure in different clinical situations,and evaluate the efficacy of P-EPSS.METHODS This retrospective observational study included a total of 180 patients who underwent closure assisted by P-EPSS(n=63)or C-EPSS(n=117)between July 2014 and June 2020.The P-EPSS and C-EPSS groups were compared and the intergroup differences in aspects such as the lesion size,location,and morphology,incidence of complete closure,intraoperative perforation,and delayed adverse events were evaluated.Data on the features and clinical course of cases with adverse events were collected for further analysis.RESULTS Patients with lesion size larger than 3 cm,lesions located at the fundus of stomach,or submucosal tumors originating from the deep mucosa were more likely to undergo P-EPSS-assisted closure.The P-EPSS group showed a significantly higher proportion of intraoperative perforation(56%vs 17%)and a much shorter procedure time(9.06±6.14 min vs 14.84±7.25 min).Among adverse events,the incidence of delayed perforation(5%vs 4%;P=0.82)and delayed bleeding(3%vs 4%;P=0.96)did not differ significantly between the groups.Multivariate analysis revealed that lesions with incomplete closure[odds ratio(OR)=21.33;95%confidence interval(CI):5.45-83.45;P<0.01]or size greater than 3 cm(OR=3.14;95%CI:1.08-9.18;P=0.039)showed a statistical tendency to result in an increase in delayed adverse events.CONCLUSION The present study revealed that EPSS could achieve secure complete closure of mucosal defect.PEPSS could shorten the procedure and yield complete closure of mucosal defects.Rather than closure-type selection,incomplete closure or lesion size larger than 3 cm were associated with worse outcomes.

Repair of oral mandibular defects with rib composite flap pedicled with internal thoracic

Objective To study feasibility and value of repair of oral mandibular defects with rib composite flap pedicled with internal thoracic vessels in basic level hospitals. Methods The clinical materials in 13 cases uith mandibular defects which were repaired with rib compos-

Novel oral-targeted therapies for mucosal healing in ulcerative colitis

Ulcerative colitis(UC), a chronic, relapsing, remitting disease of the colon and rectum, is characterized by inflammatory ulceration of the mucosa. Current UC therapy relies on controlling acute episodes and preventing relapse. To predict modifications in the natural course of UC, mucosal healing(MH) has emerged as a major treatment goal. Endoscopic evaluation is considered the gold standard for assessing MH, which can be achieved by conventional drugs and biologics in many, but not all, patients. Consequently, interest is focusing on the development of new substances for UC therapy, and new oral agents are in the pipeline. This review will focus on the ability of newly developed oral drugs to induce and maintain MH in UC patients.

Clinical and impression cytology findings of amniotic membrane and oral mucosal membrane transplantation for the management of socket contracture

AIM:To investigate and compare the cytopathological and clinical effects of amniotic membrane transplantation(AMT)and oral mucosal membrane transplantation(OMMT)in socket contraction.METHODS:Twelve patients who could not be fitted with ocular prosthesis due to socket contracture were included in this study.Seven patients underwent AMT and 5 patients underwent OMMT.Thirteen patients who had healthy sockets were included as control group.Depth of inferior fornix,degree of inflammation,extent of the socket contracture and socket volume were measured in the preoperative period and at sixth and twelfth weeks postoperatively.Impression cytology of conjunctival fornices and tear transforming growth factor beta-1(TGFβ1)levels were determined.RESULTS:In the AMT group,socket volume and lower fornix depth values were significantly higher(P=0.030and P=0.004 respectively)and inflammation levels and impression cytology stages(P=0.037 and P=0.022respectively)were significantly lower in postoperative period compared to preoperative period.In the OMMT group,no statistical differences were found in terms of clinical parameters,inflammation levels and impression cytology stages of preoperative versus postoperative values.Preoperative tear TGFβ1 levels were higher in AMT and OMMT groups compared to the control group(25.5 ng/mL,26.3 ng/mL and 21.7 ng/mL respectively).Decreased tear TGFβ1 levels were observed in both the AMT and OMMT groups postoperatively(median decrease value=2.1 ng/mL and 2.7 ng/mL respectively).CONCLUSION:AMT is associated with postoperative improvement in inferior fornix depth,socket volume,inflammation and impression cytology levels and may bea more proper alternative method than OMMT in the management of socket contracture.

Assessment of Nutritional Status of Clinical Patients by Determining Normal Range of Oral Mucosal Apoptosis and Proliferation Rate

The normal range of oral mucosal cell apoptosis and proliferation rate through a larger sample of non-malnourished crowd was investigated,and the nutritional status of clinical patients was assessed.Of 194 clinical patients selected according to 'NRS2002' guidance,there were 167 non-malnourished patients and 27 malnourished cases,respectively.Twelve patients with toxic reactions of grade III after postoperative chemotherapy (POC) were chosen.The oral mucosal epithelial apoptosis and proliferation rate were measured by using flow cytometry.The statistical significance was processed by using unpaired t-test.The results showed that there was no significant difference in gender,age and body weight between malnourished and non-malnourished groups.The normal range of oral mucosal epithelial apoptosis and the proliferation rate was (27.50±1.50)% and (15.12±1.68)% in non-malnourished patients,and that was (19.90±4.14)% and (6.66±5.83)% in the malnourished patients,respectively.It is concluded that the normal range of oral mucosa cell apoptosis and proliferation rate is achieved,which can not be influenced by gender,age,weight and other factors,and could be used as a sensitive and accurate index to assess the nutritional status of clinical patients.

The mucosal immune system in the oral cavity——an orchestra of T cell diversity

The mucosal immune system defends against a vast array of pathogens, yet it exhibits limited responses to commensal microorganisms under healthy conditions. The oral-pharyngeal cavity, the gateway for both the gastrointestinal and respiratory tracts, is composed of complex anatomical structures and is constantly challenged by antigens from air and food. The mucosal immune system of the oral-pharyngeal cavity must prevent pathogen entry while maintaining immune homeostasis, which is achieved via a range of mechanisms that are similar or different to those utilized by the gastrointestinal immune system. In this review, we summarize the features of the mucosal immune system,focusing on T cell subsets and their functions. We also discuss our current understanding of the oral-pharyngeal mucosal immune system.

Cyclodextrin/chitosan nanoparticles for oral ovalbumin delivery: Preparation, characterization and intestinal mucosal immunity in mice

A novel oral protein delivery system with enhanced intestinal penetration and improved antigen stability based on chitosan(CS) nanoparticles and antigen-cyclodextrin(CD) inclusion complex was prepared by a precipitation/coacervation method. Ovalbumin(OVA) as a model antigen was firstly encapsulated by cyclodextrin, either β-cyclodextrin( β-CD) or carboxymethyl-hydroxypropyl-β-cyclodextrin(CM-HP-β-CD) and formed OVA-CD inclusion complexes, which were then loaded to chitosan nanoparticles to form OVA loaded β-CD/CS or CM-HP-β-CD/CS nanoparticles with uniform particle size(836.3 and 779.2 nm, respectively) and improved OVA loading efficiency(27.6% and 20.4%, respectively). In vitro drug release studies mimicking oral delivery condition of OVA loaded CD/CS nanoparticles showed low initial releases at p H 1.2 for 2 h less than 3.0% and a delayed release which was below to 30% at p H 6.8 for further 72 h. More importantly, after oral administration of OVA loaded β-CD/CS nanoparticles to Balb/c mice, OVA-specific sIgA levels in jejunum of OVA loaded β-CD/CS nanoparticles were 3.6-fold and 1.9-fold higher than that of OVA solution and OVA loaded chitosan nanoparticles, respectively. In vivo evaluation results showed that OVA loaded CD/CS nanoparticles could enhance its efficacy for inducing intestinal mucosal immune response. In conclusion, our data suggested that CD/CS nanoparticles could serve as a promising antigen-delivery system for oral vaccination.

A NEW FLAP CLINICAL EXPERIENCE OF ACROMIOTHORACIC CUTANEOUS FREE FLAP FOR REPAIR OF DEFECTS IN THE ORAL AND MAXILLOFACIAL REGION

Since December 1986, acromiothoracic cutaneous flap (with its blood supply from the cutaneous perforators of deltoid muscular branches of thoracoacromial vessels) has been used for repair of the defects in the oral and maxillofacial region on 7 cases. All falps in this group survived. This skin flap must be very promising with advantages of an unexposed donor site, soft in texture and color matching the face. Moreover, the operation is less traumatic. The design and essential points of preparing the flap are introduced. The indication of operation is also discussed.

Severe Pelvic Organ Prolapse with Large Vaginal Mucosal Defect Underwent Laparoscopic Shull’s Uterosacral Ligament Colpo-Suspension and TVM Operation by Two Stage Surgery

A 75-year-old woman complained of anuria and a sense of discomfort with severe pelvic organ prolapse (POP). We planned tension-free vaginal mesh (TVM) surgery after curing mucosal defects and completing treatment for diabetes mellitus. Anuria and pyelonephritis relapsed repeatedly due to the failure of ring pessary therapy. Surgical treatment was required emergently. We performed a total laparoscopic hysterectomy and uterosacral ligament colpo-suspension (Shull’s method). Although the vaginal apex was supported to a good position, cystocele occurred six months after the initial surgery. A TVM procedure for recurrent cystocele was performed after curing the mucosal defects, and after the improvement of glycemic control. Transvaginal native tissue repair has the advantages of low risk of ureter injury, firm colpo-suspension, and no need for mesh usage. On the other hand, it is not good at treating cystocele. Transvaginal native tissue repair should prove to be a useful surgical option for apical support without mesh.

TLR5 involvement in attenuated IL-8 production in nuclear decorin silenced oral mucosal dysplastic keratinocytes and squamous cell carcinoma

Head and neck cancer is one of the most prevalent cancers in the world. Roughly half of these malignancies originate from oral mucosa and constitute Oral squamous cell carcinomas. Despite many advances in diagnostic and therapeutic regimens, five year survival rate remains at roughly 50 %, indicating the need for in depth understanding of the oral squamous cell carcinoma immunobiology. We have previously shown that in human dysplastic oral keratinocytes (DOK) and malignant squamous cells carcinoma (SCC-25), multifunctional proteoglycan decorin is aberrantly expressed and localized in the nucleus bound to nuclear EGFR. In vitro nuclear decorin knockdown significantly reduced IL-8 and IL8-dependent migration, invasion and angiogenesis in these cells. Since toll-like receptor (TLR) signalling leads to IL-8 production we examined here if these receptors play a role in decorin silencing mediated reduction in IL-8 levels. We have used immunological and molecular techniques to study toll-like receptors involvement in attenuated IL-8 production in nuclear decorin silenced (stable knockdown) oral mucosal dysplastic keratinocytes and squamous carcinoma cells. We show that nuclear decorin silenced DOK and SCC-25 cells show marked diminution of TLR5 mRNA and protein expression compared with respective controls that translated into loss of function in response to appropriate TLR ligand. In these mucosal oral epithelia, decorin stable knockdown significantly down-regulated IL-8 production following activation with TLR5 ligand flagellin. These data suggest that decorin silencing interferes with IL-8 production, in part, by altering TLR5 expression and signaling in dysplastic and malignant oral epithelia. This study highlights the significance of TLR5 expression and signaling in mucosal cancers.

A Rat Model of Autologous Oral Mucosal Epithelial Transplantation for Corneal Limbal Stem Cell Failure

Purpose: To establish an animal model of autologous oral mucosa grafting for limbal stem cell deficiency.Methods: The study was carried from August to October2012. Fourteen SD rats were randomly and evenly allocated to study group A and control group B. Limbal stem cell deficiency was established by alkali burn in the right eye of each rat in both groups. Rats in group A received autologous oral mucosa strip transplantation following the chemical burn. Rats in group B did not receive surgery after the chemical burn.Topical antibiotics and dexamethasone were used in all rats.Corneal clarity, corneal fluorescein staining, oral mucosal graft survival, and complications at postoperative days 1,3,7,14 were observed.Results: The oral mucosa strip graft was detached in one rat in group A. Reepithelialization was observed starting from the graft position and was completed within 14 days in the remaining 6 eyes in group A. However, persistent corneal epithelium defect was observed in all eyes in group B, among which corneal melting and perforation was observed in 2 eyes and corneal opacification with neovascularization was observed in the remaining 5 eyes.Conclusion: Autologous oral mucosa strip grafting for limbal stem cell deficiency can be achieved by a rat model following chemical burn. The fate of the transplanted oral mucosal epithelial cells warrants further study.

Effects of Yangyin Jiedu Decoction on Acute Oral Mucositis Caused by Radiation

[Objectives] The aim was to observe the clinical effect of Yangyin Jiedu Decoction for acute oral mucositis caused by radiotherapy for nasopharyngeal carcinoma( NPC). [Methods]Total 64 patients with non-keratinizing squamous cell carcinoma of nasopharynx were divided evenly and randomly into two groups,treatment group and control group. In the treatment group,the patients began to take Yangyin Jiedu Decoction one week before radiotherapy; while in the control group,the patients were treated with mixed solution of dexamethasone,lidocaine,recombinant human granulocyte colony stimulating factor and vitamin B12. From the beginning to the end of radiotherapy,the curative effect in the two groups was observed and compared. In addition,the levels of serum CRP,TGF-β1 and IL-6 were measured to detect the inflammatory response. [Results] The incidence of acute oral mucositis in the treatment group was significantly lower than that in the control group( P <0. 05). The effective rate was 96. 88% in the treatment group and 67. 74% in the control group. The levels of serum CRP,TGF-β1 and IL-6 in the treatment group were also lower than those in the control group. [Conclusions]Yangyin Jiedu Decoction has a good effect on prevention and treatment of acute radioactive oral mucositis and it is worthy of clinical application.

A Review of Radiation-Induced Oral Mucositis in Traditional Chinese and Western Medicine Research

Radiation therapy is one of the main treatments for head and neck tumors,and radiationinduced oral mucositis(RIOM)is a common serious adverse effect of radiation therapy.We summarized the pathogenesis,prevention and treatment methods of RIOM related to traditional Chinese and Western medicine in recent years.The treatment of RIOM in traditional Chinese medicine should be based on clearing heat and detoxifying,nourishing Yin and promoting fluid,tonifying spleen and stomach,cooling blood and removing blood stasis.Osteopontin,immunoglobulin A and saliva flow tests may be effective clinical indicators in the future.Through analysis,the author believes that the use of integrated intervention of traditional Chinese and western medicine can better benefit patients,and the prevention and predictive diagnostic tools of RIOM should become the future focus of attention.

Observation on Efficacy of Lanzhou Formula (兰州方) with Bingpeng Powder (冰硼散) Mouthwash in Preventing and Treating Radiation-induced Oral Mucositis

Objective:To observe clinical efficacy of Lanzhou Formula(兰州方)with Bingpeng Powder(冰硼散)mouthwash in preventing and treating radiation-induced oral mucositis.Methods:A total of 200 patients with malignant tumors in the head and neck who received radiotherapy in our hospital from April 2018 to April 2020 were selected as research objects,and they were randomly divided into the study group and control group.The control group was given radiotherapy combined with mouthwash,which consisted of 500 mL of normal saline,125 mg of vitamin B12,400000 U of gentamicin and 1 g of lidocaine.The study group was given radiotherapy combined with Lanzhou Formula with Bingpeng Powder mouthwash.Incidences of radiation-induced oral mucositis,chewing and swallowing functions,and Karnofsky(KPS)scores were compared between the 2 groups.Results:At the end of the radiotherapy,there was no Grade 4 radiation-induced oral mucositis in the 2 groups.Compared with the control group,the radiation-induced oral mucositis in the study group basically belonged to Grade 1 and Grade 2,with a lower incidence of Grade 3(P<0.05).At the end of the radiotherapy,the chewing and swallowing functions in the 2 groups were decreased,but patients with 2-point chewing and swallowing functions in the study group were more than those in the control group,and patients with the 3-point were less than those in the control group(P<0.05).At the end of the radiotherapy,the KPS scores were decreased,but those in the study group were higher than those in the control group(P<0.05).Conclusion:During radiotherapy for patients with malignant tumors in the head and neck,Lanzhou Formula with Bingpeng Powder mouthwash can decrease the severity of radiation-induced oral mucositis,protect chewing and swallowing functions of patients to a certain extent,and improve the general condition of patients.It is worthy of clinical application and promotion.

Effects of Kangfuxin Solution (康复新液) Combined with Low-level Laser on Cytokines and Immune Function in Patients with Radiation-induced Oral Mucositis

Objective:To investigate the effect of Kangfuxin Solution(康复新液)combined with low-level laser therapy(LLLT)on cytokines and immune function in patients with radiation-induced oral mucositis.Methods:There were 84 nasopharyngeal carcinoma patients with oral mucositis after intensity-modulated radiation therapy(IMRT)were randomly divided into the control group(CG)and the observation group(OG),with 42 cases in each group.The CG was given LLLT,and the OG was treated with Kangfuxin Solution in addition to LLLT for 10 consecutive days.The healing time of oral mucosa,mucositis grading,oral pain scores,cytokines(interleukin-6,interleukin-1βand tumor necrosis factor-α)and T lymphocyte subsets were compared between the 2 groups before and after treatment.Results:The healing time of oral mucosa in the OG was(6.8±1.4)d,which was significantly shorter than(8.6±1.9)d in the CG(t=4.943,P<0.01).After treatment,the grading of oral mucositis in the OG was better than that in the CG,with a statistically significant difference(Z=2.942,P<0.05).The oral pain scores of the OG was lower than that in the CG at different time points after treatment,and the difference was statistically significant(t=8.207,11.017,P<0.01).After treatment,the levels of IL-6,IL-1βand TNF-αin peripheral blood of the OG were significantly lower than those in the CG(t=5.217,2.775,4.053,P<0.01).There were statistically significant differences in CD4+,CD8+and CD4+/CD8+between the OG and the CG after treatment(t=5.692,6.093,3.658,P<0.01).Conclusion:Kangfuxin Solution combined with LLLT can significantly shorten the healing time of oral mucosal,reduce the grading of oral mucositis,relieve oral pain,reduce inflammatory response and improve the immune function of patients.

Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: a case–control study

The aim of this study was to evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy. Twenty patients undergoing allogeneic stem-cell transplantation for acute lymphoblastic leukaemia were treated with palifermin, and compared to a control group with the same number of subjects and similar inclusion criteria. Statistical analysis were performed to compare the outcomes in the treatment vs. control groups. In the treatment group, we found a statistically significant reduction in the duration of parenteral nutrition （P=0.002）, duration of mucositis （P= 0.003） and the average grade of mucositis （P= 0.03）. The statistical analysis showed that the drug was able to decrease the severity of mucositis. These data, although preliminary, suggest that palifermin could be a valid therapeutic adjuvant to improve the quality of life of patients suffering： from leukaemia.

A Retrospective Match Controlled Study of Supersaturated Calcium Phosphate Oral Rinse vs. Supportive Care for Radiation Induced Oral Mucositis

Oral mucositis is a common morbidity induced by radiation therapy and chemo-radiotherapy for head and neck malignancies. This often results in treatment delays, premature treatment cessation and increased cost. New treatments of oral mucositis are emerging but effective remedies remain limited. Between February 2007 and May 2008, 21 patients with head and neck malignancies were treated with a supersaturated calcium phosphate oral rinse (Caphosol) that was performed for 4-10 times daily, each consisting of two one-minute rinses. There were 21 matched patients who received supportive care without the oral rinse. All patients in the two groups were treated with intensity modulated radiation therapy (IMRT) for average prescription doses of 66 Gy in 33 fractions. The effects of this rinse vs. supportive care on mucositis, PEG tube requirements, hospitalization, xerostomia, analgesic requirements and weight was respectively evaluated. We have observed statistically significant decreases in the incidence of radiation induced oral mucositis (p=0.0002) with WHO grade 3 (38% vs. 52%) and 4 mucositis (0% vs. 19%), need for PEG tube placement (33% vs. 57%) and hospitalization (0% vs 19%). There was also a favorable impact on the incidence of grade 3 (29% vs. 43%) xerostomia in the treated patients but it was statistically insignificant (p=0.58). Incremental costs related to treatment of oral mucositis were reduced considerably. Our data suggest that use of a supersaturated calcium phosphate oral rinse is an effective treatment for mucositis in patients undergoing IMRT. It may also be helpful in the reduction of hospitalization and PEG tube requirements.

Oral and peri-oral signs and symptoms of herbal dentifrices in patients in two oral medicine clinics in Lagos—A preliminary study

Background: Herbal dentifrices appear to have become an attractive alternative for some consumers and its use has gained appreciable acceptance in Nigeria. This could be partly due to the perception that herbal toothpastes like other herbal products are “natural”, devoid of chemicals and therefore superior to regular toothpastes. Aggressive advertisement of the products may also contribute to this new trend. Mucosal symptoms such as glossitis and intolerance to spicy foods seen in patients attending the oral diagnosis clinic are usually associated with anaemia and nutritional deficiency states. The disturbing trend of an increasing number of patients presenting with such oral mucosal symptoms associated with the use of herbal dentifrices prompted this study. This trend was observed in two isolated oral medicine clinics. Objective: To sensitize oral health, allied professionals and consumers on the possible adverse effects of regular use of some herbal dentifrices sold in Nigeria. Materials and Methods: Routine patients of two oral medicine clinics in Lagos, namely the Randle General Hospital and the Lagos University Teaching Hospital who complained of some adverse mucosal signs and symptoms following the regular use of two identified herbal toothpastes made up the study population. The study was conducted between April 2010-April 2011. A detailed history and examination was carried out on these patients and clinical photographs of oral signs observed was taken in consenting patients. Data analysis was done using the Epi-info 6 software. P values ≤ 0.05 was considered statistically significant and data was presented in table format. Results: A total of 45 patients, 9 (20%) males and 36 (80%) fe-males were seen. The age range of patients was 14 - 78 years;mean age 45.5 ± 14.9 years. The duration of use of herbal dentifrices ranged from 2 weeks - 84 months (mean 24 ± 11.5 months). Oral signs and symptoms seen include, burning mouth and peppery sensation, mucosal erythema, lichenoid reaction, xerostomia, loss of taste sensation, angio-oedema and oral and peri-oral pigmentation. In many patients, resolution of symptoms was progressive within 2 weeks of withdrawal of the herbal toothpaste and its replacement with a conventional fluoride toothpaste. Most of the patients however required further treatment. A statistically significant association was found between the use of the identified herbal dentifrices and the following mucosal signs and symptoms namely, burning mouth and peppery sensation ,loss of taste sensation, soreness, erythema and lichenoid straie (p value ≤ 0.05). There was no statistically significant association between the use of herbal toothpaste and mucosal signs and symptoms of xerostomia, angular cheilitis, mucosal itching, angio-oedema and numbness (p value > 0.0.5) Conclusion: The regular use of the herbal dentifrices identified in this study can result in oral signs and symptoms affecting taste , nutrition, aesthetics and general oral physiology in some consumers. These findings suggest that further long term clinical trials need to be conducted on the herbal dentifrices to identify the noxious agents causing these symptoms. The formulation and use of these dentifrices need to be standardized and regulated. There is also a need to formulate a treatment protocol for these patients.

Development of Oral Dissolving Gelatin Beads Containing Allopurinol for the Prevention and Treatment of Mucositis

Oral dissolving gelatin beads (GBs) containing allopurinol (AP) were prepared by the seamless capsule method and their rheological properties were examined. The release profiles of both gelatin and AP from GBs were also investigated in limited dissolution medium. GBs containing AP provided an easy-to-handle dosage form, but the physical strength of the beads immediately decreased upon contact with physiological saline at 37℃. Gelatin was released from the outer layer of GBs in physiological saline, with almost all the gelatin dissolved after 5 min, together with approximately 30% of the AP contained in the inner layer of the GB. The oral administration of GBs likely results in immediate softening of the GB upon contact with saliva. The released AP acts directly at inflammation sites, in a manner similar following oral rinsing with an AP suspension. Therefore, GBs are a useful dosage form for preventing or treating localized problems in the oral cavity, such as mucositis.

Clinical relevance of the use of Dentoxol® for oral mucositis induced by radiotherapy: A phase II clinical trial

BACKGROUND Severe oral mucositis associated with cancer therapy is a frequent complication that may affect a patient's systemic condition,resulting in interruption and/or prolongation of cancer therapy.Dentoxol®is a medical solution in the form of a mouthwash that has been shown to result in statistically significant improvement in the prevention of severe oral mucositis.However,knowing the measures of the clinical significance of this therapy is important for accurate decision-making.To describe the clinical impact of Dentoxol®use in severe oral mucositis.METHODS Clinical significance was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers.The measures of clinical significance evaluated were the absolute risk or incidence,relative risk,absolute risk reduction,relative risk reduction,number needed to treat,and odds ratio.RESULTS The data obtained show that the impact of Dentoxol®on reducing the severity of oral mucositis has important clinical relevance.CONCLUSION The results of this study justify the incorporation of Dentoxol®mouth rinse into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis secondary to radiotherapy.