Effects of a mucoadhesive phytomedicine (Curcuma longa L. and Bidens pilosa L.) on radiotherapy-induced oral mucositis and quality of life of patients undergoing head and neck cancer treatment: randomized clinical trial.

PURPOSE: To assess the effect of a mucoadhesive herbal medicine containing curcuminoids and a glycerinated extract of Bidens pilosa L. (FITOPROT) in association with photobiomodulation (PBM) therapy and a Preventive Oral Care Program (POCP) compared to PBM and POCP in the treatment of radiotherapy (RT)-induced oral mucositis (ROM) and in the quality of life of these patients. METHODS: A double-blind clinical trial was performed with head and neck cancer patients undergoing RT or chemoradiotherapy. Participants were randomized into two groups: Group 1 (n=27): PBM and POCP; and Group 2 (n=25): PBM, POCP and FITOPROT. The PBM protocol was daily irradiation, 660 nm, 25mW, 0.25 J/point from the first until the last day of RT. The FITOPROT was used as mouthwash twice a day. ROM was evaluated based on the scales of the World Health Organization and National Cancer Institute. The quality of life was evaluated using the University of Washington Questionnaire, OHIP-14 and Patient-Reported Oral Mucositis Symptom Scale. The MMAS-8 questionnaire was used to evaluated the adherence to POCP and FITOPROT. Data were collected at baseline, 7th, 14th, 21st, and 30th RT sessions. RESULTS: No statistical differences were found between the groups for the ROM evaluation. Both groups experienced worsening of the quality of life during the RT. No statistically significant differences between groups were observed for any of the instruments evaluated. CONCLUSION: The results suggest that PBM associated with FITOPROT and POCP control the severity of ROM and stabilize the QoL of patients with head and neck cancer. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC-RBR-9vddmr; UTN code: U1111-1193-2066), registered in August 8th, 2017.

Immediately loaded single-implant mandibular overdentures compared to conventional complete dentures: A cost-effectiveness analysis.

BACKGROUND: In recent years, the single-implant mandibular overdenture (SIMO) has been proposed as an alternative to more complex overdenture designs as a simplified implant intervention for edentulous patients. OBJECTIVE: The aim of this study was to run a cost-effectiveness analysis alongside a randomized clinical trial comparing the SIMO and the conventional complete denture (CCD) treatment. Imediately loaded external hexagon implant and ball attachment were used for the overdenture goup. Direct costs related to therapies were identified and valuated throughout a 1-year period after delivery, in Brazilian currency (R$) and converted into international dollars (I$) using purchase power parity exchange rates. Treatment effectiveness was measured using the OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER). RESULTS: Outcomes were assessed at the 1-year follow-up for 65 patients (CCD=34; SIMO=31). Overall OHIP-Edent and satisfaction scores improved significantly in the SIMO group, while remained unchanged in the CCD group. The mean overall costs were R$1,179.04 (I$590.99) for the CCD group and R$2,127.91 (I$1,068.20) for the SIMO group - 80.7% incremental cost for SIMO. The ICER calculation for SIMO treatment showed a mean cost of I$48.20 for 1-point reduction in OHIP-Edent scores, and I$12.56 for 1-point increase in satisfaction score. CONCLUSIONS: Findings support the effectiveness of this simplified and low-cost implant intervention for edentulous patients. SIMO also seems a cost-effective alternative to the CCD and the relatively low incremental cost may potentially increase the utilization of dental implants among older subjects, especially those with limited financial resources. CLINICAL SIGNIFICANCE: The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.

Single versus two-implant mandibular overdentures using early-loaded titanium-zirconium implants with hydrophilic surface and ball attachments: 1-year randomized clinical trial.

OBJECTIVE: This randomized clinical trial aimed to compare the outcomes of the mandibular overdenture retained by one (1-IOD) or two (2-IOD) implants. MATERIALS AND METHODS: Participants received new complete dentures, were assessed at baseline and randomly assigned to groups. Early loaded single midline implant (1-IOD) or two implants in the canine regions bilaterally (2-IOD). Ball attachments were used for overdenture retention. Post-treatment outcomes (6- and 12-month follow-ups) included patient satisfaction, oral health-related quality of life measures, and chewing function. Data analysis included within- and between-group comparisons, and Generalized Estimating Equations. Both superiority and non-inferiority hypotheses were tested. RESULTS: Forty-seven participants were included (1-IOD = 23; 2-IOD = 24). Significant improvements in OHIP-Edent were observed after insertion of new dentures and at the 1-year follow-up compared with baseline. No differences were found between the 1- and 2-IOD groups for the OHIP-Edent and QoLFAST scores. Patient satisfaction with the mandibular denture improved significantly from baseline to the 6-month follow-up and remained unaltered until 1 year, with no differences between groups. The magnitudes of treatment effect sizes were moderate to large for patient-reported outcomes. Progressive improvement in chewing function occurred in both groups. Non-inferiority testing based on a 15% non-inferiority margin showed inconclusive results for patient-reported outcomes, whilst chewing function in the 1-IOD group was concluded to be not inferior to the 2-IOD group. CONCLUSIONS: Results support the use of both 1- and 2-IOD. The 1-IOD was also an acceptable alternative to the 2-IOD as a secondary option for the treatment of the edentulous mandible.

Photobiomodulation reduces the impact of radiotherapy on oral health-related quality of life due to mucositis-related symptoms in head and neck cancer patients.

To assess the effectiveness of photobiomodulation therapy (PBMT) in the oral health-related quality of life (OHRQoL) of patients with head and neck cancer undergoing radiotherapy (RT), using the Oral Health Impact Profile-14 (OHIP-14) and the Patient-Reported Oral Mucositis (OM) Symptoms Scale (PROMS), and to correlate OM degree with the PROMS and OHIP-14 scores. Forty-eight patients undergoing RT for head and neck cancer were randomly assigned into two groups: PBMT group (n = 25)-daily PBMT associated with a preventive oral care program (POCP); and control group (n = 23)-receiving POCP exclusively. OHRQoL was assessed using the PROMS and OHIP-14 questionnaires. OM degrees were classified according to the World Health Organization and the National Cancer Institute scales. Assessments were performed at the 1st, 7th, 14th, 21st, and 30th RT sessions. PBMT was effective in preventing and treating severe OM. Both groups showed increased OHRQoL impacts throughout the RT sessions; however, higher impacts were observed in the control group, mainly at the final stage of treatment (21st and 30th RT sessions). Significant correlations were found between the severity of OM and PROMS scores in the total sample and the control group at all RT periods. PROMS and OM scores were positive correlated at 14th, 21st, and 30th RT sessions in the control group, suggesting that this instrument is useful in classifying OM. PBMT was effective in treating and preventing severe OM and OM-related symptoms, and with consequent positive impacts in OHRQoL in head and neck patients undergoing RT. The PROMS scale was helpful instrument for assessment of the severity of OM. Brazilian Clinical Trials database (ReBEC - RBR-5h4y4n), registered in Aug, 24th 2017.

Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting.

OBJECTIVES: This study aimed to assess the cost-effectiveness of photobiomodulation therapy (PBMT) in association with a Preventive Oral Care Program (POCP) compared with POCP alone in the treatment of radiotherapy (RT)-induced oral mucositis (OM). METHODS: The cost-effectiveness was evaluated from the health provider perspective and conducted alongside a randomized, double-blind clinical trial. Participants were randomly assigned to either PBMT (n = 25) or control (n = 23) group. The PBMT group participants received PBMT associated with POCP. In the control group, patients were submitted to POCP alone. Costs were identified, quantified, and valued through observation and consultation of the hospital's financial sector database and estimated in Brazilian real and converted to international dollars using the purchasing power parity exchange rate. The incremental cost-effectiveness ratio (ICER) was estimated by considering the prevention of severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores, measured by the OHIP-14 and patient-reported OM symptoms scale (PROMS). RESULTS: The incremental cost of PBMT was $857.35, and the cost per session was $25.69. The ICER was $ 2867.39 to avoid one case of severe OM and $ 2756.75 to prevent one interruption in RT due to OM. ICER to reduce 1 point in OHIP-14 and PROMS scores were $170.79 and $31.75, respectively. CONCLUSION: PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions. PBMT is a promising therapy, especially to avoid interruptions in oncological treatment. TRIAL REGISTRATION: ReBEC-RBR-5h4y4n.

Religiosity, spirituality, and the quality of life of patients with sequelae of head and neck cancer.

OBJECTIVES: To investigate associations between religiosity, spirituality and quality of life (QoL) in patients with visible sequelae due to head and neck cancer surgery. SUBJECT AND METHODS: Cross-sectional study in 202 patients in a cancer hospital in Brazil. Psychosocial, demographic and clinical conditions were collected through interviews, clinical examinations and from the medical records. The outcome was QoL, measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) and the University of Washington QoL Questionnaire for patients with head and neck cancer (UW-QOL). The explanatory variables were religiosity (Duke University Religiosity Index-DUREL) and spirituality (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale-FACIT-Sp12). Pearson's correlation and linear regression were used for data analysis. RESULTS: Religiosity and spirituality were associated with both measures of the patients' QoL. After adjustment, higher scores of QoL (FACT-HN and UW-QOL) were found in patients with higher levels of religiosity and of spirituality. Other significant covariates were gender (male), those living with their families, with sequelae not involving the cervical region, longer post-surgical time and who had no chemotherapy or radiation. CONCLUSION: Religiosity and spirituality were associated with the patients' QoL, regardless of their sociodemographic and cancer-related clinical conditions and behaviours.

A prospective study on oral adverse effects in head and neck cancer patients submitted to a preventive oral care protocol.

OBJECTIVE: To evaluate the occurrence and severity of oral complications, number of radiotherapy (RT) interruptions and quality of life (QoL) in a population of head and neck cancer patients receiving a preventive oral care program (POCP) and photobiomodulation therapy (PBMT). METHODS: Prospective cohort of 61 head and neck cancer patients undergoing radiochemotherapy were monitored and submitted to a POCP that included oral hygiene and plaque control, removal of infection foci, dental restorations, periodontal therapy, fluorotherapy, oral hydration, and denture removal at night, combined with daily PBMT. Outcomes included occurrence of adverse effects such as severity of oral mucositis (OM) and oral symptoms (pain, solid and fluid dysphagia, odynophagia, dysgeusia), quality of life impacts, and interruptions of radiotherapy (RT) due to symptoms. Disease-free and overall survival rates were evaluated. RESULTS: There was a significant improvement in oral health conditions between initial assessment and the two longitudinal assessments (p < 0.05), which indicates that the POCP was effective for plaque control and reduction of gingival inflammation. All participants were free of OM at the beginning of the RT regimen and only 45.9% after the 7th session, and few patients ranked the highest score of OM. For all symptoms related to OM, there was a progressive increase of severity until the 14th RT session, which remained stable until the completion of the RT regimen. The same effect was observed for the quality of life measures. Discontinued RT due to OM occurred in only three patients (5%), and the maximum duration was 10 days. The overall survival rate was 77% and disease-free survival was 73.8%. Lower survival time was observed for patients with no response to RT (p < 0.01). CONCLUSIONS: The findings of this study suggest a positive effect of an oral preventive care program for head and neck cancer patients submitted to RT. The PBMT associated with a rigorous POCP resulted in satisfactory control of oral adverse effects, reduction of quality of life impacts, and interruption of RT regimen due to severe OM.

Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial.

BACKGROUND: Oral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients undergoing HNC treatment. Photobiomodulation is a well-consolidated and effective therapy for the treatment and prevention of severe OM, and is associated with a cost reduction of the cancer treatment. Although an increase in the quality of life and a reduction in the severity of OM are well described, there is no study on cost-effectiveness for this approach considering the quality of life as a primary outcome. In addition, little is known about the photobiomodulation effects on salivary inflammatory mediators. Thus, this study aimed to assess the cost-effectiveness of the photobiomodulation therapy for the prevention and control of severe OM and its influence on the salivary inflammatory mediators. METHODS/DESIGN: This randomized, double-blind clinical trial will include 50 HNC patients undergoing radiotherapy or chemoradiotherapy. The participants will be randomized into two groups: intervention group (photobiomodulation) and control group (preventive oral care protocol). OM (clinical assessment), saliva (assessment of collected samples) and quality of life (Oral Health Impact Profile-14 and Patient-Reported Oral Mucositis Symptoms questionnaires) will be assessed at the 1st, 7th, 14th, 21st and 30th radiotherapy sessions. Oxidative stress and inflammatory cytokine levels will be measured in the saliva samples of all participants. The costs are identified, measured and evaluated considering the radiotherapy time interval. The incremental cost-effectiveness ratio will be estimated. The study will be conducted according to the Brazilian public health system perspective. DISCUSSION: Photobiomodulation is an effective therapy that reduces the cost associated with OM treatment. However, little is known about its cost-effectiveness, mainly when quality of life is the effectiveness measure. Additionally, this therapy is not supported by the Brazilian public health system. Therefore, this study widens the knowledge about the safety of and strengthens evidence for the use of photobiomodulation therapy, providing information for public policy-makers and also for dental care professionals. This study is strongly encouraged due to its clinical relevance and the possibility of incorporating new technology into public health systems. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials-ReBEC, RBR-5h4y4n . Registered on 13 June 2017.

Effectiveness of immediately loaded single-implant mandibular overdentures versus mandibular complete dentures: A 1-year follow-up of a randomized clinical trial.

OBJECTIVE: This randomized clinical trial (RCT) aimed to assess the 1-year effectiveness of single-implant mandibular overdentures (SIMO) compared to conventional complete dentures (CCD). METHODS: In the first phase of the study, participants received new maxillary and mandibular CCDs. Then, they were randomly allocated to one of the study groups (CCD or SIMO). Participants in SIMO group received an external hexagon implant in the mandibular midline, with the immediate connection of an O-Ring/ball attachment. Oral health-related quality of life (OHIP-EDENT) and patient satisfaction in both groups were assessed before allocation and at 6- and 12-month follow-up visits. Both intention-to-treat (ITT) and per-protocol approaches were used for analyses. Statistical analyses were performed using the Wilcoxon Signed Ranks test and the Generalized Estimating Equations. RESULTS: Eighty-four participants (CCD n = 42; SIMO n = 42) were included, out of which 70 completed the 12-month follow-up (CCD n = 34; SIMO n = 36). ITT analysis showed no changes for the CCD group in the longitudinal assessment compared to baseline. Participants in SIMO group had a significant improvement in OHIP-EDENT scores and satisfaction with the mandibular denture. No changes for the maxillary denture were observed in either groups. Similar results were found when per-protocol analysis was performed. CONCLUSIONS: SIMO treatment resulted in a significant improvement in patient perceived outcomes compared to the CCD. SIMO may be considered as an alternative treatment modality for patients with poorly adapted and/or unstable mandibular dentures (ClinicalTrials.gov NCT03463174). CLINICAL RELEVANCE: The immediately loaded single-implant mandibular overdenture markedly improved patient satisfaction and oral health-related quality of life of conventional denture wearers after a 12-month follow-up.

Effect of low level laser therapy in the reduction of oral complications in patients with cancer of the head and neck submitted to radiotherapy.

The aim of this study was to assess the effect of low level laser therapy on reducing the occurrence and severity of oral complications in patients with head and neck cancer undergoing radiotherapy. Sixty head and neck cancer outpatients from a cancer hospital receiving radiotherapy were selected and randomly assigned into two groups. The laser group was irradiated with an InGaAlP laser and the control received sham laser. The assessment of complications (oral mucositis, pain) was carried out one week after starting radiotherapy, and at the fifteenth and thirtieth sessions of radiotherapy. All patients from both groups showed some degree of oral mucositis. Better outcomes were observed in the laser group when compared with the control in the follow-up sessions, indicating lower degrees of oral mucositis, pain and higher salivary flow (p < .05). These findings support the use of laser therapy as an adjuvant treatment for the control of oral complications.

Effect of salivary stimulation therapies on salivary flow and chemotherapy-induced mucositis: a preliminary study.

OBJECTIVE: The objective of this study was to evaluate the effect of salivary stimulation therapies on the salivary flow, oral mucositis, and salivary cytokine levels in patients receiving allogeneic hematopoietic stem cell transplantation. STUDY DESIGN: Thirty-five eligible patients were randomized into 4 groups: control, mechanical sialogogue, transcutaneous electrical nerve stimulation (TENS) sialogogue, and combined mechanical/electrical sialogogue. Saliva was collected from patients before transplantation and at days 3, 7, and 14 after transplantation. The volume was measured and salivary cytokines were assessed using enzyme-linked immunosorbent assay. RESULTS: By day 14, resting and stimulated salivary flow levels were diminished. Resting salivary flow rates decreased the most in the control and mechanical groups. In contrast, TENS alone or in combination with mechanical stimulatory therapy benefited the patients. TENS-treated patients showed increase in resting salivary flow. Also, the groups treated with TENS had fewer patients affected by grades 3 and 4 mucositis, and less mucositis was associated with better patient survival (P = .027). CONCLUSIONS: TENS-associated salivary stimulation therapies minimized the reduction of salivary flow and prevented severe chemotherapy-induced oral mucositis.

Effect of intraoral low-level laser therapy on quality of life of patients with head and neck cancer undergoing radiotherapy.

BACKGROUND: Low-level laser therapy has been used to reduce complications of head and neck cancer treatment. The aim was to assess the impact of laser in the quality of life (QOL) of patients receiving radiotherapy. METHODS: Sixty outpatients were randomly assigned into 2 groups. The laser group received applications and the placebo group received sham laser. QOL was assessed using the University of Washington QOL questionnaire. A repeated-measures analysis of variance (ANOVA) was used for comparisons of overall QOL scores and Mann-Whitney test compared changes in domain scores. RESULTS: A decrease in QOL scores was observed in both groups and the reduction in the laser group was significantly lower (p < .01). Changes in QOL scores regarding pain, chewing, and saliva domains were evident in the placebo group. Both health-related QOL and overall QOL were rated higher by patients who received laser therapy. CONCLUSION: Laser therapy reduces the impact of radiotherapy on the QOL of patients with head and neck cancer.

Kinesiographic study of complete denture movement related to mucosa displacement in edentulous patients.

The mucosa that covers the residual ridges of edentulous patients may present some distortion or displacement when occlusal loading is applied in complete dentures. This distortion and movement of the denture can result in acceleration of residual ridge resorption and loss of retention and stability. The aim of this study was to analyze the pattern of upper complete denture movement related to underlying mucosa displacement. A sample of 10 complete denture wearers was randomly selected, which had acceptable upper and lower dentures and normal volume and resilience of residual ridges. The kinesiographic instrument K6-I Diagnostic System was used to measure denture movements, according to the method proposed by Maeda et al.7, 1984. Denture movements were measured under the following experimental conditions: (A) 3 maximum voluntary clenching cycles and (B) unilateral chewing for 20 seconds. The results showed that under physiological load, oral mucosa distortion has two distinct phases: a fast initial displacement as load is applied and a slower and incomplete recovery when load is removed. Intermittent loading such as chewing progressively reduces the magnitude of the denture displacement and the recovery of the mucosa is gradually more incomplete.

Estudo retrospectivo dos fatores associados à longevidade de próteses totais. Parte I: Avaliação subjetiva e queixas dos pacientes / Retrospective study of factors associated to complete dentures longevity. Part I: Patient's subjective evaluation and complaints

O presente estudo avaliou a freqüência de queixas subjetivas e o julgamento dos pacientes em relação às próteses totais por eles utilizadas. Foram entrevistados 103 pacientes, em períodos que variavam entre 1 e 11 anos após a instalação das próteses. Dos pacientes entrevistados, 74 por cento e 64 por cento ainda utilizavam as próteses superior e inferior, respectivamente. Dos pacientes que ainda utilizavam a prótese superior, 38,2 por cento consideraram essa condição regular ou ruim, enquanto 48,5 por cento julgaram a prótese inferior e regular ou ruim, sendo que as queixas mais freqüentes foram relacionadas a problemas de retenção e estabilidade para a prótese superior e de retenção, estabilidade e traumatismos para a prótese inferior. Dentre todos os pacientes com queixas subjetivas em relação às próteses, os motivos para a não substituição das mesmas relatados com maior freqüência foram a falta de motivação do paciente, falta de tempo para se submeterem ao tratamento e dificuldades financeiras. Dentre os motivos relatados com maior freqüência para a não utilização da prótese, foram problemas de traumatismo e estética relacionados à prótese superior e deficiências relacionadas a traumatismos, retenção e estabilidade da prótese inferior. Os resultados reforçam a necessidade do controle posterior e acompanhamento periódico do tratamento. Além disso, o conhecimento das necessidades e limitações individuais de cada paciente em particular é essencial para o sucesso do tratamento com próteses totais