Prevalência de relato seletivo de desfechos em ensaios clínicos randomizados sobre tratamento periodontal não cirúrgico / Prevalence of selective outcome reporting in randomized controlled trials of non-surgical periodontal treatment

O relato seletivo de desfecho (RSD) é um tipo de viés de relato, e ocorre quando um desfecho primário de um protocolo de estudo é alterado ou omitido, quando um novo desfecho é introduzido na publicação, ou quando há alteração do time point que foi pré-especificado no protocolo. RSD pode subestimar ou superestimar o efeito de uma terapia. Por isso, pode distorcer os resultados de revisões sistemáticas e alterar a percepção do público e comunidade científica sobre a eficácia de intervenções. O tratamento periodontal não cirúrgico (TPNC) é uma das terapias mais investigadas na periodontia. Até o momento, não há na literatura informações sobre a prevalência de RSD em estudos de TPNC. Assim, o objetivo deste estudo foi avaliar a presença de RSD em publicações de ensaios clínicos randomizados (ECRs) de TPNC, além de verificar os fatores associados. A busca e seleção dos protocolos dos estudos sobre TPNC foi realizada na plataforma ClinicalTrials.gov em 06 de janeiro de 2021. As respectivas publicações foram identificadas e a extração de dados e análise de possíveis discrepâncias entre protocolo e publicações foi realizada. O risco de viés dos estudos incluídos foi avaliado de acordo com a ferramenta RoB2. Foram incluídos 141 estudos (170 publicações). RSD esteve presente em 49,6% das publicações, e em 27,7% delas não foi possível identificar se houve RSD uma vez que o desfecho primário não foi relatado adequadamente na publicação ou no registro. RSD esteve associado com significância estatística (p < 0.001) e com mais de uma publicação referente ao mesmo protocolo (p< 0.05). Além disso, a especificação do desfecho primário e o risco de viés de cada estudo foram avaliados. Dos 180 desfechos primários avaliados nas publicações, apenas 37,2% estavam completamente definidos, com informações de domínio, medida específica, métrica específica e time point adequadamente determinadas. Dos 141 estudos, a maioria (58,1%) apresentou alto risco de viés. Em contrapartida, apenas um estudo (0,7%) foi classificado com baixo risco de viés. O risco de viés foi caracterizado por algumas preocupações em 41,1% dos casos. O presente estudo identificou alta prevalência de RSD em ECRs sobre TPNC, evidenciando a necessidade de relatar resultados de ensaios clínicos de modo mais detalhado e transparente.

Efficacy of mouthrinses in reducing oral SARS-COV-2 load: a review

Abstract Accumulated evidence has shown that the oral cavity may be an important reservoir for SARS-CoV-2. Some authors have suggested that the use of mouthrinses could reduce SARS-CoV-2 viral load in the saliva. Thus, the aim of this review was to synthesize evidence about the efficacy of mouthrinses in reducing the salivary viral load of SARS-CoV-2. 2. Nine randomized controlled trials (RCTs) have investigated the efficacy of different mouthrinses in reducing salivary SARS-CoV-2 loads. Various active ingredients have been tested in these trials: 0.5%,1% and 2% povidone-iodine, 0.2% and 0.12% chlorhexidine (CHX), 0.075% cetylpyridinium chloride (CPC), 0.075% CPC with Zinc lactate, 1% and 1.5% hydrogen peroxide (HP), 1.5% HP + 0.12% CHX and ß-cyclodextrin and citrox. The studies reported an intra-group reduction in the salivary levels of the virus, when compared with the baseline. However, the majority of these trials failed to demonstrate a significant inter-group difference between active groups and the control group relative to the decrease in salivary SARS-CoV-2 loads. Although promising, these results should be confirmed by larger trials.

Impacto de cesación de tabaquismo en la calidad de vida relacionada a la salud bucal de fumadores con implantes oseointegrados / The impact of tobacco cesation on life quality related to oral health

El tabaquismo es un importante factor de riesgo para las enfermedades periodontales y periimplantares. Los fumadores tienen más posibilidades de presentar pérdida de dientes e implantes y puede promover un impacto negativo en la calidad de vida relacionada a la salud bucal (QVRSB). Este estudio prospectivo tiene como objetivo verificar el impacto de la cesación de tabaquismo sobre la QVRSB de pacientes fumadores que recibieron implantes oseointegrados. Todos los participantes recibieron terapia antitabáquica y rehabilitación protética implantosoportada. Fue aplicado un cuestionario OHIP-14 para evaluar la calidad de vida relacionada a la salud bucal. La exposición a tabaco fue evaluada por dedio de un cuestionario estructurado y validado por medición de los niveles de monóxido de carbono expirado. Pacientes que consiguieron dejar de fumar (NF) fueron comparados con pacientes fumadores que no consiguieron dejar de fumar(F) en relación al OHIP-14. Durante el período de estudio, fueron incluídos 83 pacientes, de los cuales 77 permanecieron hasta el final del estudio. La media de cigarros fumados por día fue de 14,3 y un número medio de años de tabaquismo fue de 29,8 años. Hubo reducción significativa de los escores medios de OHIP-14 en los dos grupos: que dejaron de fumar que no consiguieron de dejar de fumar. Por otro lado, no hubo diferencia entre los grupos en relación a la media de OHIP-14. Dentro de los límites del estudio, concluímos que dejar de fumar no tiene impacto significativo en la calidad de vida relacionada a la salud bucal (AU)

Selective outcome reporting in root coverage randomized clinical trials.

BACKGROUND: Outcome discrepancies between protocols and respective publications represent a concerning bias. The purpose of this study was to assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs). METHODS: Published root coverage RCTs (July 2005 to March 2020) were included if a corresponding protocol could be identified in a public registry. Discrepancies between protocol and its correspondent publication(s) were compared regarding primary and secondary outcomes and other study characteristics. Associations between trial characteristics and SOR were evaluated. RESULTS: Forty four studies (54 publications) were included. The majority of studies (77.3%) were retrospectively registered. SOR was frequent (40.9% of trials) and consisted of primary outcome downgrade (22.7%); secondary outcome upgrade (11.4%); new primary outcome introduced in publication (25%); protocol primary outcome omitted from publication (13.6%) and discrepancy in primary outcome timing (18.2%). SOR was unclear in 20.5% of studies and favoured statistical significance in 12 studies (27.3%). SOR was significantly associated with study significance (p < 0.001) and unclear outcome definition in the publication (p < 0.001). Only a third (32.8%) of primary outcomes were completely defined. CONCLUSIONS: The present study identified high prevalence of SOR in root coverage RCTs.

Randomized clinical trials in periodontology: focus on outcomes selection

Abstract Randomized clinical trials (RCTs) are human studies carried out to compare different treatments or interventions, and their results are used to support clinical decision-making and improve patient care. Herein, the aim of this study was to review the selection process of study outcomes in periodontology. Primary outcomes should draw the main conclusions of the study, whereas secondary outcomes should only be used to help explain the main findings and generate future research hypothesis. Outcomes are classified as clinically relevant (CROs) or surrogate outcomes. CROs - the first option for primary outcome variables - should convey not only substantial health benefits, but also be deemed important by patients. In periodontology, tooth loss/retention and oral health-related quality of life (OHRQoL) are examples of CROs. While tooth loss has main limitations as a primary outcome, emerging evidence suggest that patient-reported outcome measures (PROMs) can accurately detect OHRQoL following periodontal therapy. When CROs cannot be assessed, validated surrogate outcomes can be used as proxies. Primary outcome variables should reflect a treatment endpoint at the patient level that can be easily used to inform decision-making in daily practice. These outcomes should allow the implementation of a treat-to-target concept in which the intervention can be clearly judged against a prespecified treatment target. Recently, the presence of at most 4 sites with periodontal probing depth ≥5 mm post-treatment was suggested as an effective endpoint for periodontal trials. In perspective, a combination of validated clinical parameters and PROMs will provide a more comprehensive assessment of periodontal treatments.

Severity of oral lichen planus and oral lichenoid lesions is associated with anxiety.

OBJECTIVES: Oral lichen planus (OLP) and oral lichenoid lesions (OLL) are chronic inflammatory diseases whose symptoms can impair patient's quality of life (QoL). Psychological factors seem to play an important role in these diseases. This study aimed to determine the impact of oral health and anxiety levels on the QoL of patients with OLP and OLL. PATIENTS AND METHODS: This was a cross-sectional study composed of OLP and OLL patients and a control group matched by age and sex with no autoimmune/inflammatory or malignant oral lesions. Anxiety levels and oral health impact on QoL were assessed using the Hamilton Anxiety Scale (HAM-A) and the Oral Health Impact Profile-14 (OHIP-14), respectively. The instruments were filled through personal interview before starting the treatment for oral lesions. RESULTS: A total of 87 patients diagnosed with OLP (n = 45) and OLL (n = 42), and 87 controls were included in the study. Statistical differences were observed for the psychic and somatic anxiety dimensions between severities of diseases. Patients with OLP or OLL had higher scores for the OHIP-14 dimensions physiological discomfort and social limitation compared with controls. In addition, higher scores for physical pain, physical disability, social disability, and handicap were detected among patients with greater severity. CONCLUSION: Greater severity of OLP and OLL seems to be associated with increased levels of anxiety, higher scores of oral health impact profile, and decreased QoL. CLINICAL RELEVANCE: Patients with severe OLP/OLL may benefit from additional therapeutic treatments, such as psychological and/or psychiatric management, concomitant to treatment specific to oral lesions.