This randomized clinical study aimed to compare the clinical and radiographic outcomes of TheraCal PT and Biodentine in pulpotomy treatment of primary teeth and to evaluate the influence of low-level laser therapy (LLLT) on treatment outcomes in pediatric patients.
This prospective randomized clinical trial was conducted at Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry. The study included healthy children aged 4 to 9 years who required pulpotomy treatment for primary molar teeth. Eligible teeth were randomly allocated into four groups according to the pulpotomy material used and the application of low-level laser therapy (LLLT): (1) Biodentine, (2) LLLT + Biodentine, (3) TheraCal PT, and (4) LLLT + TheraCal PT. Low-level laser therapy was performed using a 940 nm diode laser in non-contact mode immediately after coronal pulp removal. All treated teeth were restored with stainless steel crowns. Clinical and radiographic evaluations were scheduled at baseline and at 3, 6, and 12 months follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.
After pulpotomy, diode laser (940 nm, 10 s, non-contact mode) was applied over the pulp chamber floor, followed by placement of Biodentine (Septodont, France).
After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.
Tokat Gaziosmanpasa University Faculty of Dentistry
Tokat Province, Turkey (Türkiye)
Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars
Number of teeth with clinical success defined as absence of spontaneous pain, swelling, sinus tract, pathological mobility, or tenderness to percussion, and number of teeth with radiographic success defined as absence of internal or external root resorption and absence of furcal or periapical radiolucency. Results will be reported as number and percentage of successful teeth.
Time frame: 12 months after treatment
Interim Clinical and Radiographic Success Rates
Number of teeth meeting clinical and radiographic success criteria at interim follow-up visits, reported as number and percentage of successful teeth.
Time frame: 3 and 6 months after treatment
Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success
Difference in the proportion of clinically and radiographically successful teeth between the laser-treated groups and non-laser groups, expressed as number and percentage of successful teeth.
Time frame: 12 months after treatment
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Following pulpotomy, a 940 nm diode laser (Biolase, USA) was applied for 10 seconds in non-contact mode, followed by application of TheraCal PT (Bisco Inc., USA).