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

November 28, 2025 updated by: NECIBE DAMLA ŞAHIN

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Tokat Province, Turkey (Türkiye)
        • Tokat Gaziosmanpaşa University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biodentine
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
After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.
Other Names:
  • biomaterial
Experimental: LLLT + Biodentine
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
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
Experimental: TheraCal PT
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
After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.
Experimental: LLLT + TheraCal PT
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 6 months after treatment
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.
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NECIBE DAMLA ŞAHIN

Collaborators

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Necibe Damla ŞAHİN, DDS, PhD, Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry, Tokat, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Actual)

July 5, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/92 (Other Identifier: Tokat Gaziosmanpasa University, BAP Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because this study involved pediatric participants and the data contain potentially identifiable information. Only summary data will be available in the published article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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