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OBJECTIVE: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. MATERIALS AND METHODS: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on portable breath meter) Breath Alert™ (Tanita Corporation®-Japan), were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The hypothesis of normality in the data was discarded by the Shapiro-Wilk test (p < 0.05) and for statistical analysis the Wilcoxon and Mann-Whitney tests were used. RESULTS: A significant difference was found between the pre-treatment reading and all other readings (p < 0.05) in both groups, suggesting the effectiveness of the proposed treatments. No significant difference was found between the post-treatment reading and two follow-up readings, suggesting the maintenance of the effect of treatment over time (p > 0.05). However, significant differences were found between groups for all post-treatment assessments (p < 0.0001 for all comparisons), indicating greater effectiveness with aPDT. No association was found between the initial reading and the presence of coated tongue. CONCLUSION: Antimicrobial photodynamic therapy using annatto and blue LED proved to be a viable therapeutic option for the treatment of halitosis in mouth-breathing children.

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OBJECTIVE: To assess the effectiveness of the REFIX technology in the remineralization process of initial caries simulated on bovine enamel. The assessment involved the analysis of backscatter intensity, which was determined from laser speckle images. METHOD: Twenty-one bovine teeth were divided into three groups: G1 and G7 were submitted to treatment with the REFIX technology for 1 and 7 days, respectively. The control group was treated with deionized water. RESULTS: A significant difference in backscatter was found between the carious and sound areas in all groups (p = 0.0038, p < 0.0001, and p = 0.0002 for the control group, G1, and G7, respectively). The intergroup comparison revealed no significant difference among the groups studied. CONCLUSION: REFIX technology did not alter the optical properties of the samples of bovine teeth with simulated initial caries lesions after 1 and 7 days of treatment.

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OBJECTIVE: This study aimed to evaluate the effect of antimicrobial photodynamic therapy (aPDT) and the use of probiotics on the treatment of halitosis. METHODS: Fifty-two participants, aged from 18 to 25 years, exhaling sulfhydride (H2S) ≥ 112 ppb were selected. They were allocated into 4 groups (n = 13): Group 1: tongue scraper; Group 2: treated once with aPDT; Group 3: probiotic capsule containing Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg), 3 times a day after meals, for 14 days; Group 4: treated once with aPDT and with the probiotic capsule for 14 days. Halimetry with gas chromatography (clinical evaluation) and microbiological samples were collected from the dorsum of the tongue before and after aPDT, as well as after 7, 14, and 30 days. The clinical data failed to follow a normal distribution; therefore, comparisons were made using the Kruskal-Wallis test (independent measures) and Friedman ANOVA (dependent measures) followed by appropriate posthoc tests, when necessary. For the microbiological data, seeing as the data failed to follow a normal distribution, the Kruskal-Wallis rank sum test was performed with Dunn's post-test. The significance level was α = 0.05. RESULTS: Clinical results (halimetry) showed an immediate significant reduction in halitosis with aPDT (p = 0.0008) and/or tongue scraper (p = 0.0006). Probiotics showed no difference in relation to the initial levels (p = 0.7530). No significant differences were found in the control appointments. The amount of Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola were not altered throughout the analysis (p = 0.1616, p = 0.2829 and p = 0.2882, respectively). CONCLUSION: There was an immediate clinical reduction of halitosis with aPDT and tongue scraping, but there was no reduction in the number of bacteria throughout the study, or differences in the control times, both in the clinical and microbiological results. New clinical trials are necessary to better assess the tested therapies. TRIAL REGISTRATION: Clinical Trials NCT03996044.

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BACKGROUND: To compare photodynamic therapy and the use of probiotics in reducing halitosis assessed through gas chromatography and microbiome analysis. METHODS: Participants aged from 18 to 25 years showing sulfide (SH2) ≥ 112 ppb on gas chromatography were selected. They were divided into four treatment groups: Group 1-Tongue Scraping; Group 2-Antimicrobial Photodynamic Therapy (aPDT); Group 3-Probiotics; and Group 4-Antimicrobial Photodynamic Therapy (aPDT) and Probiotics. The halimetry process was performed before, immediately after the treatments, and 7 days, 14 days, and 30 days after the initial collection. The collections for later microbiological analysis were made along with the halimetry for microbiome analysis. RESULTS: Treatment with aPDT or probiotics under these experimental conditions was not able to change the bacteria present in the biofilm of the tongue. CONCLUSIONS: More research is needed to know the behavior of the oral microbiome in the presence of halitosis and the effectiveness of new treatments.

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Photobiomodulation is a safe option for controlling pain, edema, and trismus when applied postoperatively in third molar surgery. However, administration prior to surgery has been under-explored. This study aims to explore the effectiveness of pre-emptive photobiomodulation in reducing postoperative edema in impacted lower third molar extractions. Two groups of healthy individuals undergoing tooth extraction will be randomly assigned: Control group receiving pre-emptive corticosteroid and simulated photobiomodulation, and Photobiomodulation Group receiving intraoral low-intensity laser and extraoral LED cluster application. The primary outcome will be postoperative edema after 48 h. The secondary outcomes will be pain, trismus dysphagia, and analgesic intake (paracetamol). These outcomes will be assessed at baseline as well as two and seven days after surgery. Adverse effects will be recorded. Data will be presented as means ± SD and a p-value < 0.05 will be indicative of statistical significance.

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Molar incisor hypomineralization (MIH) is a qualitative developmental defect of enamel that occurs during the mineralization phase. Patients with MIH have increased risk of caries, hypersensitivity, and restoration failures. The present case report describes the treatment of a 10-year-old patient exhibiting two teeth with atypical carious lesions. A minimal interventive protocol was instituted combining antimicrobial photodynamic therapy and the selective chemical-mechanical removal of the carious tissue using the product Papacárie Duo®. This protocol is promising for the decontamination and control of hypersensitivity in teeth with MIH.

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INTRODUCTION: Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control. METHODS AND ANALYSIS: Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the χ2 test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations. ETHICS AND DISSEMINATION: This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05443035.

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The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (NIET) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The aim of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of (NIET) in primary teeth associated with the use of two obturator pastes. One hundred and twenty necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, root canals will not be instrumented, just irrigated and filled with the respective pastes, antibiotic (CTZ) and iodoform (Guedes-Pinto). Presence of fistula and mobility will be clinically evaluated. The evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. For the main outcome, the tooth will be the unit of analysis and the Kaplan-Meier test will be performed to estimate the survival rates of the included teeth. For comparison between the two groups, Student's t test or Mann-Whitney test will be performed, depending on the normality of the data. In addition, Poisson regression analyzes will be carried out, in order to allow the evaluation of the influence of some variables on the results. For all analyses, the significance value will be adjusted to 5%. Trial registration: NCT04587089 in ClinicalTrials.gov. Approval date: May 15, 2023.

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INTRODUCTION: The objective is to investigate the effect of antimicrobial photodynamic therapy (aPDT) mediated by erythrosine and a blue light-emitting diode (LED) in the reduction of bacteria in dental biofilm. METHODS AND ANALYSIS: This clinical trial will be conducted with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the Dental Clinic of Universidade Metropolitana de Santos. A split-mouth model will be used (n=30), with group 1 control (conventional treatment) and group 2 (conventional treatment and aPDT). The bicarbonate jet will be used to remove dental biofilm in both groups. The treatment will be carried out in one session. aPDT will be performed before cleaning/prophylaxis, only in group 2. Participants will rinse with the photosensitiser erythrosine (diluted to 1 mM) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. Then, the D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ=470 nm, radiant power of 1000 mW, irradiance of 0.532 W/cm2 and radiant exposure of 63.8 J/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min/point (4 cm2). The microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. Collection will be performed in each experimental site before irradiation, immediately after the irradiation procedure and after the prophylaxis. Colony-forming units will be counted and the data will be submitted for statistical analysis for comparison of pretreatment and post-treatment results and between groups (conventional X aPDT). ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Universidade Metropolitana de Santos under process number 66984123.0.0000.5509. Results will be published in peer-reviewed journals and will be presented at conferences. TRIAL REGISTRATION NUMBER: NCT05805761.

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INTRODUCTION: Photobiomodulation has been widely used as a complementary treatment for dentin hypersensitivity, with reports of clinical success. However, the literature offers only one study, in which photobiomodulation was used for the treatment of sensitivity in molars with molar incisor hypomineralisation (MIH). The aim of the proposed study is to determine whether photobiomodulation enhances the results of treatment with glass ionomer sealant on molars with MIH that present sensitivity. METHODS AND ANALYSIS: The study involves 50 patients from 6 to 12 years of age that will be randomly allocated in two groups. Group 1 (control group) (n=25): toothpaste with a concentration of fluoride ≤1000 ppm two times a day, glass ionomer sealant and sham low-level laser (LLL) and group 2 (n=25): toothpaste with a concentration of fluoride ≤1000 ppm two times a day, glass ionomer sealant and active LLL. The evaluations will involve MIH record, Simplified Oral Hygiene Index (OHI), Schiff Cold Air Sensitivity Scale (SCASS) and visual analogue scale (VAS) before the procedure. Immediately after the procedure, the hypersensitivity index (SCASS/VAS) will be registered. Records of OHI and SCASS/VAS will be registered after 48 hours as well as 1 month after the procedure. The persistence of the sealant will also be registered. It is expected that by the second consultation, a decrease in sensitivity will be observed due to the treatments received in the two groups. ETHICS AND DISSEMINATION: This protocol has been approved by the local medical ethical committee (certificate: CEUCU 220516). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05370417.

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INTRODUCTION: Halitosis is a term that defines any odor or foul smell the emanates from the oral cavity, the origin of which may be local or systemic. One of the causes of local or oral halitosis is low salivary flow and dry mouth, which is also one of the complaints of individuals with the mouth-breathing habit. The aim of this study is to determine the effectiveness of antimicrobial photodynamic therapy (aPDT) and the use of probiotics for the treatment of halitosis in mouth-breathing children. METHODS: Fifty-two children between 7 and 12 years of age with a diagnosis of mouth breathing and halitosis determined through an interview and clinical examination will be selected. The participants will be divided into 4 groups: Group 1-treatment with brushing, dental floss and tongue scraper; Group 2-brushing, dental floss and aPDT applied to the dorsum and middle third of the tongue; Group 3-brushing, dental floss and probiotics; Group 4-brushing, dental floss, aPDT and probiotics. The use of a breath meter and microbiological analysis of the tongue coating will be performed before, immediately after treatment and 7 days after treatment. The quantitative analysis will involve counts of colony-forming bacteria per milliliter and real-time polymerase chain reaction. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test. DISCUSSION: Due to the low level of evidence, studies are needed to determine whether treatment with aPDT using annatto as the photosensitizer and blue led as the light source is effective at diminishing halitosis in mouth-breathing children.

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BACKGROUND: This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD). METHODS: This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1-ILIB with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 2-Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 3-Control with no treatment (n = 15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ± 20%, wavelength 808 nm ± 10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures. DISCUSSION: Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.

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BACKGROUND: According to the World Health Organization (WHO), dental caries is considered one of the greatest pediatric health problems in the world, due to its high prevalence and incidence. Therefore, the early diagnosis of caries lesions is a fundamental procedure for planning treatment aimed at prevention, minimal intervention and promotion of oral health. The present study aims to evaluate, through a randomized and controlled clinical study, which is the best strategy for diagnosing primary caries lesions located in the interproximal region. MATERIALS AND METHODS: Eighty patients, aged between 4 and 10 years will be randomized and allocated into 2 groups for analysis and comparison of methods for diagnosing caries lesions. The following diagnostic methods will be analyzed and compared: visual clinical examination using ICDAS (International Caries Detection and Assessment System), the iTero Element 5D System (intraoral scanner with near infrared imaging (NIRI) technology) and bitewing radiography (BWX). All evaluations will be carried out by 02 examiners. Examiners will be trained and calibrated to use the visual and radiographic criteria and also to use the iTero 5D intraoral scanner, following the manufacturer's instructions. TRIAL REGISTRATION: NCT04900246 in ClinicalTrial.gov. First released in 05/11/2021 and last updated in 10/06/2021.

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The aim of the study was to evaluate the release of the lingual frenulum through frenectomy in newborns zero to 90 days of age who breastfed and had diagnosis of ankyloglossia with an indication for surgery, comparing two methods: electrocautery and a high-power diode laser. Fifty-seven patients were randomly allocated to two groups (23 submitted to electrocautery and 34 submitted to a high power diode laser). Tongue movements were evaluated based on a clinical assessment and using the Bristol Tongue Assessment Tool (BTAT) before and 15 days after the surgical procedures. The visual analog scale was administered to the mothers on the same occasions for the measurement of pain during breastfeeding. Both groups had an increased BTAT score (favorable outcome) at the post-surgical evaluation, but the anterior third of the tongue was not always free to enable the movements necessary for lingual functions. It is fundamental for surgeons to have skill and in-depth knowledge of the equipment used to avoid accidents and complications in the region of important structures. Both techniques employed in this study were safe and effective, causing little bleeding and few postoperative complications. The group submitted to a high-power diode laser exhibited less post-surgical bleeding compared to the group submitted to electrocautery and no inflammation at the edges of the surgical cut.

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OBJECTIVES: To evaluate the effect of PBM on the psychological profile and quality of life of patients with oral lichen planus (OLP) in comparison to corticoid and to investigate the cost-effectiveness of both treatments. MATERIALS AND METHODS: Patients were randomized into two groups: Control (clobetasol propionate 0.05%) and Photobiomodulation (660 nm, 100mW, 177 J/cm2, 5 s, 0.5 J) twice a week for 30 days. The Hospital Anxiety and Depression Scale (HADS) and OHIP-14 were used in different treatment time points and at follow-up. The cost-effectiveness was calculated using the improvement in OHIP-14 after treatment. RESULTS: OLP patients showed detected levels of anxiety, depression, and poor quality of life at baseline. No improvement in anxiety and depression was noticed after treatments. However, PBM and corticoid significantly improved the quality of life of OLP patients, considering the OHIP-14-T and the physical pain domain. The treatment with corticoid was more cost-effective than PBM. CONCLUSIONS: Psychological distress was not improved after both treatments and PBM is as effective as corticoids in promoting a better quality of life in OLP patients, despite its higher cost. CLINICAL RELEVANCE: This study highlights the need for additional therapeutic interventions in OLP patients, to early recognize and to manage the alterations in their psychological profile. Moreover, PBM is an effective therapy in OLP patient's quality of live and although it was a more expensive, the advantage of being a minimally invasive therapy associated with no side effects must be considered in clinical practice, especially in those patients with refractory disease. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov; the registration number is NCT03320460, registered in 17/10/2017.

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INTRODUCTION: Ankyloglossia (tongue-tie) is an anomaly characterised by an abnormally short, thick or small lingual frenulum that restricts tongue movements. This condition is considered one of the factors that can interfere with breast feeding by diminishing the ability of the newborn to latch adequately. According to the Brazilian Health Ministry, the prevalence of this anomaly among newborns is 3%-16%. Frenectomy is the most suitable surgical procedure for the treatment of ankyloglossia. The aim of this study is to compare the performance of electrocautery and high-power diode laser as forms of frenectomy. METHODS AND ANALYSIS: The proposed study will be a randomised, controlled, blind clinical trial involving the participation of healthy infants 0-3 months of age with breastfeeding difficulty and a diagnosis of tongue-tie with an indication for lingual frenectomy. The guardians will receive clarifications regarding the procedures and will authorise the participation of the infants by signing a statement of informed consent. A non-blinded researcher will perform the screening and procedures and a blinded researcher will perform the postoperative evaluations. Fifty-six infants will be randomly allocated into two groups (n=28): the electrocautery group or the high-power laser group. The preparation of the patients, asepsis and infection control procedures will rigorously follow biosafety norms. For both groups, patient histories will be taken, clinical evaluations will be performed and a standardised photograph of the lingual frenulum will be taken before surgery. The Bristol Tongue Assessment Tool will be used. We will evaluate pain in the mother during breast feeding before, immediately after, and 15 days after surgery. ETHICS AND DISSEMINATION: This protocol was submitted to the Research Ethics Committee of Nove de Julho University, having been given a favourable opinion (Number: 4387769). Results will be submitted to international peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT04487418.

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BACKGROUND: Photobiomodulation (PBM) is a non-invasive and non-pharmacological treatment, which, has shown beneficial results in the treatment of temporomandibular disorders (TMD) related pain. This systematic review and meta-analysis study aimed to evaluate the efficacy of photobiomodulation in the treatment of myofascial pain associated with (TMD by analyzing randomized clinical trials published from 2007 to February 2019. The secondary objective of the study was to perform a cost-effectiveness analysis of TMD treatment with photobiomodulation in patients with myofascial pain. MATERIAL AND METHODS: International databases were used: Pubmed, Medline and Web of Science; the initial search raised 316 papers, and only 17 papers met the inclusion criteria for the systematic review (SR). Of these, only 04 papers met the inclusion criteria for meta-analysis: VAS data represented by numerical scores and placebo control group. RESULTS: As for the wavelength, the most used value was 780nm (followed by 830nm. The most used treatment time was 4 offered treatments for 4 weeks; followed by 10 sessions. Regarding periodicity, 9 studies used 2 times a week. The meta-analysis showed that laser-treated groups had painful symptoms improvement that was superior to the control group (mean difference 1.49;95% CI = -1.67; -1.32). Laser therapy showed a cost-effectiveness of $1,464.28 by controlled pain intensity and placebo showed $2,866.20 by controlled pain intensity. CONCLUSIONS: The studies were considered to have moderate quality of evidence. Laser-treated groups had painful symptoms improvement that was superior to the control group and photobiomodulation was more cost-effective than placebo in patients with TMD and myofascial pain. Key words:Temporomandibular disorder, Myofascial pain, Photobiomodulation, Placebo, Cost-effectiveness.

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Background: Pain during labor can be a barrier when choosing vaginal delivery. In an attempt to relief pain during labor, several pharmacological and nonpharmacological methods are proposed. Objective: To assess the effect of light-emitting diode (LED) photobiomodulation on analgesia during labor. Methods: A clinical trial was conducted with 29 women who were divided into two groups: G1 (experimental group-LED) and G2 (control group-hot shower). In the experimental group, an LED plate with red and infrared merged [red 660 ± 20 nm, 5 mW/cm2, 3 J per LED (108 J) and infrared 850 ± 20 nm, 5 mW/cm2, 3 J per LED (108 J), total energy = 216 J] was placed on the subjects' dorsal region, at the level of T10 to S4, for 10 min, with the plate automatically turning off. Hot shower at controlled temperature was offered for 30 min. To verify the effect of LED on analgesia during labor, the following variables were assessed: (1) perception of pain, (2) fetal well-being assessed by cardiotocography or intermittent auscultation of fetal heart rate, (3) Apgar score at minutes 1 and 5 after birth, and (4) labor duration. Results: There was a statistically significant difference (p < 0.05) in pain reduction evidenced by a millimetric visual scale, before and after application on G1-LED (7.92 ± 1.78). Regarding the other variables, there was no statistical difference between the groups when comparing fetal well-being, Apgar score and labor duration. Conclusions: It is concluded that LED can be considered an alternative, since it caused pain reduction without changing other parameters during labor, compared with hot shower, a method included in hospital protocols, proving to be safe. Clinical Trial Registration number: NCT03496857.

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INTRODUCTION: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH. METHODS AND ANALYSIS: One hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment. ETHICS AND DISSEMINATION: This protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT04407702.

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BACKGROUND: Oral mucositis (OM) is an oral toxicity caused by cancer treatment, found often in patients with head and neck cancer. Low-intensity laser therapy for OM has anti-inflammatory, analgesic, and tissue reparative properties. OBJECTIVE: The objective of this work is to perform a systematic review and meta-analysis of the randomized clinical trials of OM laser therapy in patients undergoing treatment for head and neck cancers, followed by a cost-effectiveness analysis of the therapy. METHOD: The search terms, mucositis and phototherapy, laser therapy and mucositis, photobiomodulation and mucositis, and low-level laser therapy and mucositis, were used to search the databases of PubMed, Web of Science, and MEDLINE. Randomized clinical trials were divided into two groups: one treated with laser therapy and the other given a placebo. Only 13 studies were included in the systematic review, and 6 studies in the meta-analysis. RESULTS: The results of the systematic review and meta-analysis show that the laser therapy presented good results in clinical improvement and pain reduction, decreasing the patients' likelihood of developing OM, with degrees of debilitating lesions, to 64% (RR = 0.36 [95% CI = 0.29-0.44]). The cost-effectiveness analysis revealed an incremental cost of R$ 3687.53 for the laser group, with an incremental effectiveness of 132.2. The incremental cost-effectiveness ratio (ICER) was 27.89, for the severe OM cases that were avoided. CONCLUSION: It was concluded, therefore, that photobiomodulation for OM in patients receiving head and neck cancer treatment was clinically effective and cost-effective.

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