Comparison of Treatment Outcome of Pulpotomy With Versus Without Dental Operating Microscope in Carious Mature Permanent Teeth : A Randomized Controlled Trial

Materials and methods Study design and setting This study is a prospective, single-center, single-blinded, parallel-group, randomized controlled trial conducted at the Dental Department, Phaholponpayuhasena Hospital. All clinical procedures are performed by a single experienced endodontist. Clinical outcome evaluations are carried out by the same operator, while radiographic outcome evaluations are conducted by another experienced endodontist.

Study participants Inclusion Criteria

• Healthy patients aged at least 18 years old with deep or extremely deep carious lesions in mature permanent teeth diagnose with asymptomatic or symptomatic irreversible pulpitis. Diagnoses are confirmed using EPT and cold tests. Pulpal and periapical diagnoses are based on terminology from the American Association of Endodontists (AAE, 2013)20.
• Teeth are restorable with direct composite restoration. Exclusion Criteria
• Teeth with subgingival caries and/or clinical attachment loss more than 3 mm and probing depth more than 4 mm.
• Negative responses to pulp sensibility tests, presence of sinus tracts, swelling, non-restorable crowns, immature roots, or no pulp exposure following complete caries removal in case of pre-operative diagnosis as asymptomatic irreversible pulpitis.
• Patients with systemic diseases involving bleeding disorders such as hemophilia, Von Willebrand disease, platelet disorders. And patients under taking all kind of anticoagulant and anti-platelet.
• Teeth with pulpal obliteration.
• Necrotic pulp is found after access opening
• Bleed cannot be stopped within 8 minutes after full pulpotomy21,22

Treatment procedure A comprehensive medical and dental history is taken before treatment. Preoperative data, including age, sex, tooth number are recorded in a predesigned patient's chart. The treatment, the study design, alternative treatment modalities, potential benefits, risks, and follow-up protocol are explained to the qualifying patients and informed consent is obtained from the voluntary patients who are willing to participate in the study.

Sample size calculation The sample size calculation is based on a suspected difference of 39.2% in the success rate between the control and magnification group in MB2 orifice finding using n4Studies with a 5% α error. The minimum sample size was calculated to be 46. Considering patients lost to follow-up, a total of 50 teeth from different patients are included in this study.