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

NCT07276685 | Completed

• 1 other identifier: 2022/92
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Tooth Pulpotomy; Vital Pulp Therapy

Keywords

Primary Tooth; Pulpotomy; TheraCal PT; Biodentine; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after treatment

Secondary Outcomes (2)

• Interim Clinical and Radiographic Success Rates

  3 and 6 months after treatment

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

  12 months after treatment

Study Arms (4)

Biodentine

ACTIVE COMPARATOR

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.

Procedure: Biodentine Pulpotomy

LLLT + Biodentine

EXPERIMENTAL

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).

Device: Low-Level Laser Therapy + Biodentine

TheraCal PT

EXPERIMENTAL

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.

Procedure: TheraCal PT Pulpotomy

LLLT + TheraCal PT

EXPERIMENTAL

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).

Device: Low-Level Laser Therapy + TheraCal PT

Interventions

Biodentine Pulpotomy PROCEDURE

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

Also known as: biomaterial

Biodentine

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).

Also known as: Laser and biomaterial

LLLT + Biodentine

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.

TheraCal PT

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).

LLLT + TheraCal PT

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NECIBE DAMLA ŞAHIN: lead
• Tokat Gaziosmanpasa University: collaborator

Study Sites (1)

Tokat Gaziosmanpasa University Faculty of Dentistry

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Biocompatible Materials; Low-Level Light Therapy; Lasers

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture; Laser Therapy; Therapeutics; Phototherapy; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Necibe Damla ŞAHİN, DDS, PhD

  Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry, Tokat, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to the treatment groups during clinical and radiographic evaluations. Participants and operators were not blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study was designed as a parallel-group randomized clinical trial. Sixty primary molars from children aged 4-9 years were randomly assigned to four intervention groups according to the material used (Biodentine or TheraCal PT) and the use of low-level laser therapy (LLLT).

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 11, 2025
• Study Start: January 5, 2023
• Primary Completion: July 5, 2025
• Study Completion: October 15, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)