The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment of Deep Dentinal Caries: a Randomized Clinical Trial.

Sample Size Determination Method and Total Number of Subjects for the Study:

The study will span 24 months, and a total of 144 patients meeting the inclusion criteria will be selected from those seeking treatment at the Endodontics clinic of Ondokuz Mayıs University Faculty of Dentistry.

An a priori power analysis was performed using the treatment success rate parameter under the "Survival Analysis: Comparison of Two Survival Curves - Lachin" section at the link: Survival Analysis: Comparison of Two Survival Curves - Lachin. Based on the treatment success rates in the study by Asgary et al. (2015) - 76.1% for vital pulp therapy and 75.6% for root canal treatment, with a type I error of 0.05 and a beta value of 0.95, a minimum sample size of 30 per group was calculated. Considering a 20% follow-up loss, 36 subjects per group will be included (n = 36).

Patients within the age range of 18-65, systemically healthy, with upper and lower jaw molars, deep dentin caries, and no known allergies to materials and drugs used in root canal treatment, will be assessed for inclusion criteria in the endodontics clinic. Pulp sensitivity tests using cold and electric pulp tests will be conducted. If the pulp chamber does not become exposed after caries removal or if necrosis is detected in at least one canal (with no bleeding) after cavity preparation, the voluntary participant will be excluded from the study, and appropriate treatment will be completed. Radiological examination will evaluate the presence of radiolucent lesions in periapical areas using periapical radiographs taken from different angles. Teeth with a periapical index value greater than 1, indicating radiolucency observed in apical periodontitis, will be excluded (Orstavik 1986). Teeth that cannot be isolated with a rubber dam, for which coronal obturation cannot be achieved, teeth with fractures, advanced periodontal disease, and teeth with multiple lost cavity walls will be excluded from the study.

Before starting the treatment, patients will randomly select one of four sealed envelopes containing the name of the study group. The envelope will be sealed until the randomization phase (before cavity preparation after local anaesthesia and isolation) to ensure that the operator remains unaware of the study group name. Patients will be informed about the visual analogue scale (VAS) and quality of life scales related to oral health before the treatment.