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

NECIBE DAMLA ŞAHIN

Status: Completed

Conditions: Primary Tooth Pulpotomy; Vital Pulp Therapy

Treatments: Procedure: Biodentine Pulpotomy; Device: Low-Level Laser Therapy + TheraCal PT; Procedure: TheraCal PT Pulpotomy; Device: Low-Level Laser Therapy + Biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT07276685

2022/92

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy children aged between 6 and 9 years. Primary molars with carious exposures requiring pulpotomy treatment. Teeth with vital pulp confirmed by the absence of spontaneous pain and the presence of normal bleeding after coronal pulp removal.

Teeth with restorable crowns suitable for stainless steel crown restoration. Cooperative patients who can attend all follow-up appointments.

Exclusion criteria

Teeth with signs of irreversible pulpitis or necrosis (e.g., spontaneous or nocturnal pain).

Teeth with internal or external root resorption, furcal or periapical radiolucency.

Non-restorable teeth or those with excessive loss of crown structure. Patients with systemic diseases or on long-term medication that could affect healing.

Uncooperative children or those lost to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Biodentine

Active Comparator group

Description:

Primary molars treated with pulpotomy using Biodentine without low-level laser therapy (LLLT). After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.

Treatment:

Procedure: Biodentine Pulpotomy

LLLT + Biodentine

Experimental group

Description:

Primary molars treated with Biodentine pulpotomy combined with low-level laser therapy. 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).

Treatment:

Device: Low-Level Laser Therapy + Biodentine

TheraCal PT

Experimental group

Description:

Primary molars treated with pulpotomy using TheraCal PT without low-level laser therapy. After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.

Treatment:

Procedure: TheraCal PT Pulpotomy

LLLT + TheraCal PT

Experimental group

Description:

Primary molars treated with TheraCal PT pulpotomy combined with low-level laser therapy. 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).

Treatment:

Device: Low-Level Laser Therapy + TheraCal PT