This study protocol was approved by the Institutional ethical board (no. KFSIRB200-1). In this study, it is necessary to include 48 intact mandibular first molars for 4 groups (n = 12) to be able to analyse inter-observer and intra-observer compatibility. Sound teeth that were extracted for periodontal reasons were selected and stored in distilled water at room temperature. Teeth with external or internal root resorption, anomalies, fractures, cracks, and immature apices were not included in the study. Any hard deposits on the teeth were removed using sharp curettes, and soft deposits were removed by soaking the teeth in a 5.25% sodium hypochlorite solution (NaOCl) for 30 minutes. The endodontic access cavities were prepared, and a #10 K-file was used to verify the canal's patency. The working length of the mesial roots was measured to be 1 mm short of the estimated true canal length after a #10 K-file was inserted into the canal until its tip was visible at the apical foramen. The two mesial root canals were instrumented in each tooth using Protaper Next rotary systems (PTN, Dentsply Maillefer, Ballaigues, Switzerland) up to X2 files (size 25, apical taper 6%). At each instrument change during the instrumentation procedure, the canals were irrigated with a 2.5% NaOCl solution. Following instrumentation; to make the canal efficiently clean and remove any remaining debris passive ultrasonic irrigation using an Irrisafe 20/21 file (Satelec, Merinac Cedex, France) was used. After that, 2 mL of distilled water was used to rinse the canals. Throughout the experiment, all teeth were kept moist with water.
The teeth were divided randomly into four groups (n = 12) according to presence or absence of strip perforation and presence or absence of root obturation as the follows: (i) no strip perforation and no obturation of the mesial canals, (ii) no strip perforation and obturation of the mesial canals, (iii) strip perforation and no obturation of the mesial canals, (iv) strip perforation and obturation of the mesial canals. To perform root canal perforation, Gates Glidden drill No. 1 (Dentsply Maillefer, Ballaigues, Switzerland) was used in the coronal third of the mesiolingual root canal until the perforation was made at the distal surface of the mesial canal. The perforation defect was confirmed by a size 20 K-file through the perforation area. For root canal obturation, root canals were dried using paper points. AH plus sealer was mixed according to the manufacturer’s instructions, and mater cone gutta-percha cone size 25 with a 0.04 taper was coated with the sealer and placed into the root canal. The roots were filled using the lateral condensation technique with a spreader and standard size 20 gutta-percha cones. After that, a hot instrument was used to cut off the gutta-percha to the level of the canal orifices. For radiographic techniques and evaluation, the teeth were inserted into prepared sockets in dry human mandibles in the posterior area. Three coats of dental wax were applied to the buccal and lingual surfaces of the mandibles to resemble soft tissue. The wax layer was 1.5 mm thick all around. To secure the teeth in the mandibular holes and fill spaces between the root surface and the socket, impression material (Elite HD, Zhermack, Italy) was utilised. Intraoral digital PR were taken using a Gendex X-ray unit (Gendex Digital Systems, Hatfield, PA) operating at 65 kVp, 7 mA, and 0.2 s exposure time. The GXPS-500 PSP (photostimulable phosphor plate) was used with a parallel technique and three horizontal angles, including the direct angle, 10o mesially, and 10o distally (Figure 1). The visibility of enamel, dentine, and pulpal root canals were used as indicators for the best image quality. Additionally, using the ProMax® 3D Max CBCT equipment (Planmeca, Helsinki, Finland), CBCT images at two different voxel sizes 0.2 mm3 (CBCT-0.2) (Figure 2) and 0.4 mm3 (CBCT-0.4) (Figure 3) were obtained at 96 kVp, 1 mA, with a 55 x 50 mm FOV and exposure periods ranging between 12 and 15 s. The CBCT pictures were examined in the three reconstruction planes, comprising the axial, coronal, sagittal, and multiplanar reconstruction images with a slice thickness of 0.1 mm and an interval of 0.1 mm. A specific calibration session using 10 images that were not included in the study was conducted prior to the interpretation process. Image sets were viewed separately by six blinded, calibrated observers in intraoral digital PR and CBCT assessment, three pairs of observers participated in this study: two general practitioners, two endodontists, and two dentomaxillofacial radiologists. The observers did not participate in the samples preparation, and they were blind to the results of the other imaging technique. All images were randomised within each imaging technique; no time limit was placed on the observers. Image sets were viewed individually at 1-week intervals, and evaluations of each image set were repeated 1 week after the initial viewings, and if there was a difference between them, a final decision was asked for each observer independently, they examined the images using a monitor (LG Flatron 18.5-inch, Seoul, Korea) in a low-lit room and graded their observations as ‘perforation’ or ‘no perforation’. After that, each pair of observers discussed the cases together with the possibility of perforation until a consensus was reached.
Statistical analysis:
The data were collected and analysed using SPSS version 17.0 (SPSS Inc., Chicago, IL, USA). Cohen’s kappa values (k) were used to calculate intra-observer (difference in repeated measurements by the same observer) and inter-observer agreement (difference in the measurements between two observers). Kappa values were interpreted as the following criteria: <0.10 = no agreement; 0.10–0.40 = poor agreement; 0.41–0.60 = moderate agreement; 0.61–0.80 = strong agreement; and 0.81–1.00 = excellent agreement [14]. The area under the receiver operating characteristic curves (AUC) with standard errorE) and 95% confidence interval (CI) was calculated; the AUC values under 0.5 correspond to scores with no discrimination ability, whereas values 1 correspond to perfect discrimination. AUC values for each image mode and observer were compared using z tests, and the significance level was set at p = 0.05. Se, Sp, NPV, and PPV with a confidence interval (CI 95%) of both CBCT scans and PR for the detection of the perforations were also calculated.