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NCT Number: NCT07276685

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

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.

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Key information

Conditions

Primary Tooth Pulpotomy Vital Pulp Therapy

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa University Faculty of Dentistry

Tokat Province, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biodentine Pulpotomy

Procedure

After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.

Other names: biomaterial

Low-Level Laser Therapy + Biodentine

Device

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).

Other names: Laser and biomaterial

TheraCal PT Pulpotomy

Procedure

After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.

Low-Level Laser Therapy + TheraCal PT

Device

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).

Primary outcomes

  1. Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars

    Time frame: 12 months after treatment

    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.

Secondary outcomes

  1. Interim Clinical and Radiographic Success Rates

    Time frame: 3 and 6 months after treatment

    Number of teeth meeting clinical and radiographic success criteria at interim follow-up visits, reported as number and percentage of successful teeth.

  2. Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success

    Time frame: 12 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

NECIBE DAMLA ŞAHIN

Other

Collaborators

  • Tokat Gaziosmanpasa University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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