NCT07276685

Evaluation of the Success of TheraCal PT in Pulpotomy Treatment of Primary Teeth Using Low-Level Laser Therapy

Evaluation of the Success of TheraCal PT and Biodentine in Pulpotomy Treatment of Primary Teeth and the Effect of Low-Level Laser Therapy (LLLT) on Treatment Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: NECIBE DAMLA ŞAHIN · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Tooth Pulpotomy
• Vital Pulp Therapy

Interventions

Type	Name	Description
PROCEDURE	Biodentine Pulpotomy	After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.
DEVICE	Low-Level Laser Therapy + Biodentine	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).
PROCEDURE	TheraCal PT Pulpotomy	After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.
DEVICE	Low-Level Laser Therapy + TheraCal PT	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).

Timeline

• Start date: 2023-01-05
• Primary completion: 2025-07-05
• Completion: 2025-10-15
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: Turkey (Türkiye)