Level of Patient Comfort and Measurement Reliability of Three Different Probes: a cross-sectional study

<b>METHODOLOGY</b><b>Study design and ethical considerations.</b><b> </b>This was a cross-sectional observational study. The manuscript was prepared in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.¹⁴ The protocol was approved by the research ethics committee of the Universidad Científica del Sur, Lima, Peru (Protocol # 260 CIEI) and was conducted in accordance with the Declaration of Helsinki of 1964, in its revised form (2008). Volunteers seeking dental care at the Universidad Científica del Sur (Lima, Peru) were informed of the details of the study, instructed about its risks, and told that they were free to withdraw at any time. All patients signed a term of free and informed consent prior to beginning with the measurements. The study was conducted at the postgraduate clinic of the Universidad Científica del Sur.<br><b>Clinical evaluations </b><b> </b>Three experienced periodontists (&gt; 10 years of clinical experience), trained and calibrated, performed the clinical evaluations throughout the study. During pre-determined appointments, the volunteers were submitted to a periodontal clinical evaluation lasting approximately 10 minutes per each probe with 20 minutes intervals between measurements. This evaluation was carried out once a week for 3 consecutive weeks. Each week the periodontal evaluation was performed by a different examiner using the different probe models. The results were recorded in a data collection sheet. At the end of the last evaluation, in the third week, all participants received dental prophylaxis, free of charge. Acrylic guides were made for all participants, with respect to the teeth to be evaluated (# 16, # 21, # 24, # 36, # 41, # 44). In each acrylic model, 3 gutters were made (mesial, central, and distal) in the guides, so that each evaluator made the measurement in the same place. Measurements of probing depth from the mesial to central and distal regions of the buccal surfaces of the teeth were recorded in the respective patient’s record chart. <b>Patient-reported outcomes</b><b>Patient Questionnaire (Pain)</b> The patients were given thorough verbal information on how to use the pain scale. Feedback from the patients was asked for to make certain that they understood the nature of the scale. Instructions on how to use the VAS scale were also written on the scale forms. The patients were also assured that their VAS pain responses would not be disclosed to the treating therapist. Patient discomfort (pain) was measured using a visual analogic scale (VAS 0-10). At the end of each periodontal evaluation, all the volunteers filled out the VAS questionnaire to record the comfort experienced during the evaluation.