$$\rightleftharpoonup{xx}$$
$$\longleftharp{xx}$$,
$$\longrightharp{xx}$$,
This study was approved by the Medical Ethics Committee of the Second People’s Hospital of Yibin City. Written informed consent was obtained from all participants prior to enrollment in accordance with the Declaration of Helsinki. This work was supported by the 2023 Scientific Research Project of the Yibin Municipal Health Commission (Grant No. 2023YW014) and the Natural Science Foundation of Sichuan Province (Grant No. 2023NSFSC0546).
1. Study design and participants
This randomized controlled study involved 94 patients who received microscope-assisted root canal treatment for MB2 periapical disease affecting maxillary first molars at the Stomatology Center of the Second People's Hospital of Yibin City from January 2023 to December 2024. The study protocol was approved by the Medical Ethics Committee of the Second People's Hospital of Yibin City (Approval No. 2023-136-01, approved on June 12, 2023). Participants were randomly allocated to the experimental group (n = 47) or the control group (n = 47). Written informed consent was obtained from all participants prior to enrollment after a detailed explanation of the study objectives, procedures, and potential risks.
The inclusion criteria were as follows: (1) patients requiring root canal treatment of maxillary first molars; (2) imaging examination confirming apical foramen closure and complete root development, with radiographic evidence of unobstructed canal anatomy suggestive of root canal patency; (3) presence of apical radiolucency with a diameter ≤5 mm; and (4) provision of informed consent and willingness to cooperate with the treatment.
Exclusion criteria included extensive tooth defects and/or poor periodontal condition (as periodontal breakdown may alter root anatomy, compromise isolation, and affect accurate MB2 localization), previous root canal treatment requiring retreatment, tooth fractures, temporomandibular joint disorders (e.g., restricted mouth opening), and severe systemic diseases that could influence healing response, pain perception, or treatment outcomes.
2. Diagnostic and radiographic examination
Preoperative assessment included intraoral periapical radiography or CBCT, depending on clinical indication. While CBCT provides superior three-dimensional visualization of root canal anatomy, periapical radiographs were used as an initial screening tool, with CBCT employed selectively to enhance detection and assessment of complex canal morphology. Under a dental microscope, the pulp chamber and root canal anatomy were examined. The number and morphology of root canals were recorded, and MB, distobuccal, and palatal root canal systems were classified according to the Weine classification17.
3. Treatment procedure
Preoperative evaluation was performed for all affected teeth to assess restorability and case complexity based on clinical and radiographic findings, followed by rubber dam isolation. Under a dental microscope, all carious tissue and pulp remnants were removed. The working length was determined using an apex locator set at 0.5 reading and verified with periapical radiography. When necessary, ultrasonic instruments were employed to remove pulpal calcifications and canal obstructions, and passive ultrasonic irrigation (PUI) was used for irrigant activation using an ultrasonic tip placed short of the working length.
Root canal instrumentation was carried out using NiTi rotary files at 300 rpm and 2.0 N·cm torque, with sequential irrigation using 5 mL of 1% sodium hypochlorite (NaOCl) between each file, followed by a final rinse with 5 mL of 0.9% saline. After ultrasonic cleaning, the canals were dried using sterile paper points (size 30–40) until no visible moisture remained, after which a calcium hydroxide paste was applied as an intracanal medicament using a lentulo spiral. Patients were followed for 1–2 weeks until the treated tooth was asymptomatic, with no exudate or odor, before proceeding with root canal filling.
4. Control group
Root canal filling was performed using the AH Plus hot vertical compaction technique under a dental microscope. AH Plus sealer was applied, and a heated gutta-percha tip was compacted incrementally. The heat carrier was set to 180 °C and applied for 2–3 seconds per increment, maintaining an apical pressure of approximately 1.5 N to achieve dense compaction of the gutta-percha.
5. Experimental group
The single-tip bioceramic filling method was performed under a dental microscope. The sealant was injected into the canal until it reached the orifice, followed by the slow insertion of a single gutta-percha point to displace any air bubbles. Excess gutta-percha was removed at the orifice using a heat carrier, and compaction was performed.
For teeth in the control group, separate AH Plus hot vertical compaction was conducted for the MB and MB2 canals due to their proximity or fusion. In contrast, in the experimental group, simultaneous MB and MB2 filling was performed using the single-tip bioceramic technique, followed by orifice compaction.
Postoperative radiographs were obtained to assess the quality of obturation after the preparation of the pulp chamber and removal of excess sealer or gutta-percha. The total root canal filling time was recorded for both groups. All procedures were performed by a single experienced endodontist, and coronal restoration was completed within 1–2 weeks following root canal filling.
6. Observation indicators and evaluation criteria
1. Radiographic assessment of root canal filling
Postoperative apical X-rays were taken to assess the filling quality of the MB, MB2, distobuccal (DB), and palatal (P) root canals, based on established radiographic criteria evaluating filling length and homogeneity18. Radiographs were taken using a digital intraoral sensor (70 kVp, 8 mA, exposure time 0.25 s) and were analyzed using ImageJ software to measure filling length and homogeneity. The root canal filling was deemed optimal when the filling material was dense, displayed a continuous taper, and extended 0.5–2 mm from the apical foramen. Overfilling was characterized by the filling material extending past the apical foramen, whereas underfilling was identified when the filling material was positioned more than 2 mm from the apex or did not adequately seal the apical region.
2. Procedural time measurement
The total time needed to fill all four root canals in the maxillary first molars was documented for comparative analysis between the two groups. Procedure time was measured from the start of sealer application to the removal of excess gutta-percha at the canal orifice. Timing was recorded using a digital stopwatch operated by an independent observer to ensure consistency and minimize measurement bias.
3. Postoperative pain assessment
Patients were followed up at 24 h and 7 days postoperatively to assess pain levels using the Visual Analogue Scale (VAS), a validated tool for pain assessment19. Pain scores were self-reported via telephone by a blinded investigator using a standardized 10-point VAS form. Participants were advised to refrain from using analgesics unless pain was severe; any analgesic intake was recorded during follow-up. The VAS scores were categorized as follows: 0 points - No pain or postoperative discomfort; 1-3 points - Mild pain, with minimal discomfort; 4-6 points - Moderate pain, tolerable without medication; 7-10 points - Severe pain, requiring analgesics or emergency intervention.
4. Clinical efficacy evaluation
Clinical efficacy was evaluated at 6 months post-treatment according to established endodontic outcome criteria, based on radiographic and symptomatic improvements20: (1) Significant improvement: Complete resolution of periapical pathology, with the disappearance of clinical symptoms and signs; (2) Effective: Considerable reduction in the radiolucent periapical lesion, with marked improvement in clinical symptoms; (3) Ineffective: No improvement or worsening of periapical radiolucency, with persistent or worsening clinical signs.
The treatment success rate was calculated as:
Treatment response rate = (significant improvement + Effective) X 100%
These outcome criteria were adapted from established clinical evaluation systems for endodontic treatment success17.
7. Statistical analysis
Data were analyzed statistically using SPSS 26.0. Normality of continuous variables was assessed. The mean plus or minus the standard deviation (x ± s) was used to display data that was normally distributed, and data from separate samples were also used. In order to compare the groups, t-tests were used. Data that did not follow a normal distribution were expressed as median (interquartile range) [M (Q1, Q3)], and group comparisons were performed using the Mann-Whitney U test.
Categorical variables were presented as frequencies and percentages [n (%)], and group comparisons were carried out using either Fisher's exact test or the chi-square (χ2) test, depending on what was relevant. Ordinal data were compared using the Mann-Whitney U test. The threshold for statistical significance was established at P < 0.05.