A Randomized Clinical Trial Comparing Hydraulic Cements in Partial Pulpotomy in a Madrid Population: Impact of Clinical and Procedural Variables on Treatment Outcomes

Study design and ethics This prospective single-arm randomized clinical trial followed the Preferred Reporting Items for Randomized Trials in Endodontics (PRIRATE) guidelines. After approval from the Institutional Investigation and Ethical Committee (CI: 2023-305 ) the research was conducted in the Department of Endodontics of the University . All participating patients were thoroughly informed about the advantages and disadvantages of opting for partial pulpotomy, as well as the differences and implications of choosing this treatment option over conventional endodontics. Furthermore, all patients signed an informed consent form, acknowledging the alternatives and associated risks. Only those patients who provided informed consent for the proposed treatment were included in the final analysis Sample size The sample size was determined using the conventional formula for estimating a single proportion. Assuming an anticipated success rate of 90% for the Vital Pulp Therapy procedure, a 95% confidence level (Z = 1.96) and an allowable margin of error of 7% were considered appropriate. The margin of error was set at 7% to balance statistical precision with clinical feasibility, acknowledging that in the context of vital pulp therapy, such a margin provides a reliable estimate of treatment success while accommodating practical limitations in patient recruitment and follow-up. Accordingly, the calculated minimum sample size was 71 cases.

Participant recruitment

From December 2022 to December 2023, patients presenting to the Department of Endodontics at the University were screened for eligibility. Inclusion criteria comprised patients diagnosed with initial, mild, moderate, or severe pulpitis according to the Wolters et al. (2017) classification, aged between 18 and 88 years, and having a non-contributory medical history. Furthermore, only permanent teeth affected by caries and exhibiting a proximity to the pulp-assessed via periapical and bitewing radiographs-with a distance ranging from 0 to 1.5 mm were selected. In addition, selected teeth were required to have fully formed apices, a periapical index score of ≤2, no tenderness on percussion, and probing pocket depths and mobility within normal limits. Exclusion criteria were defined as follows: patients diagnosed with pulp necrosis according to the American Association of Endodontists (AAE) guidelines; patients who declined vital pulp therapy as a treatment option; and patients with systemic conditions that could affect treatment outcomes. Additionally, teeth were excluded if they exhibited immature roots; if no pulp exposure occurred despite complete caries excavation; if bleeding after pulpal amputation could not be controlled within the prescribed time (10 minutes); if the pulp chamber was exposed to the oral environment; if insufficient bleeding was observed after pulp exposure-indicating necrotic or partially necrotic pulp; or if there was evidence of pathological root resorption, fracture or calcification. A total of 97 cases were initially analyzed, and after excluding 26 cases due to patient refusal of VPT, the predetermined sample size of 71 cases was reached. Enrollment was subsequently discontinued, as this number met the sample size requirements established by our statistical calculation. This approach ensured that the study maintained adequate power while preserving sample homogeneity, with all patients being treated by a single operator to guarantee procedural standardization.

Pulpal Diagnosis Pulpal diagnosis was established via a comprehensive clinical evaluation, emphasizing patient-reported symptoms. Cold thermal sensitivity was assessed using cotton pellets moistened with a cold spray Endo Frost Roeko (Coltene, Altstätten, Switzerland). The thermal response was quantified in two dimensions: intensity and duration. Intensity was rated on a scale from 0 to 10, where 0 denotes no pain, 1-3 indicate mild pain, 4-6 indicate moderate pain, and 7-10 indicate severe pain. Duration was evaluated on a scale from 1 to 4, with a score of 1 corresponding to 1-10 seconds, 2 to 11-20 seconds, 3 to 21 seconds up to 1 minute, and 4 to more than 1 minute. To assess and classify the patient's preoperative pain, the Numeric Rating Scale was employed. Other diagnostic tests included digital palpation, percussion with a mirror handle, periodontal probing using a CP-12 probe (Hu-Friedy), and transillumination to detect fractures.

In addition, radiographic assessments were conducted using periapical radiographs with a positioning device and bitewing radiographs, thereby ensuring full visualization of the tooth structure and at least 2 mm of the surrounding periapical tissue.