Primary Tooth PulpotomyNCT07276685
Evaluation of the Success of TheraCal PT in Pulpotomy Treatment of Primary Teeth Using Low-Level Laser Therapy
A study testing Biodentine Pulpotomy, Low-Level Laser Therapy + Biodentine and TheraCal PT Pulpotomy in people with Primary Tooth Pulpotomy and Vital Pulp Therapy, run by NECIBE DAMLA ŞAHIN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Tooth Pulpotomy, Vital Pulp Therapy
- What is being tested?
- Biodentine Pulpotomy, Low-Level Laser Therapy + Biodentine and TheraCal PT Pulpotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University Faculty of Dentistry
Tokat Province
About this study
Official 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
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.
Read the 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
- Being tested
- Biodentine Pulpotomy, Low-Level Laser Therapy + Biodentine, TheraCal PT Pulpotomy, Low-Level Laser Therapy + TheraCal PT
- Keywords
- Primary Tooth, Pulpotomy, TheraCal PT, Biodentine, Low-Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine PulpotomyProcedure or surgery
Also called biomaterial
After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.
Low-Level Laser Therapy + BiodentineDevice
Also called Laser and biomaterial
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).
TheraCal PT PulpotomyProcedure or surgery
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 PTDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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). Receives: Device: Low-Level Laser Therapy + TheraCal PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after treatment
Secondary outcomes (2)
Interim Clinical and Radiographic Success Rates
Number of teeth meeting clinical and radiographic success criteria at interim follow-up visits, reported as number and percentage of successful teeth.
Measured: 3 and 6 months after treatment
Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success
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.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start5 Jan 2023
- Primary completion5 Jul 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Tooth PulpotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NECIBE DAMLA ŞAHIN
- Sponsor type
- University, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Responsible party
- Sponsor-investigator, NECIBE DAMLA ŞAHIN, Tokat Gaziosmanpasa University
- Investigators
- Necibe Damla ŞAHİN, DDS, PhD, Principal investigator, Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry, Tokat, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276685
- Sponsor's protocol ID
- 2022/92
- Other IDs
- 2022/92
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07276685
- Acronym / sponsor ID
- 2022/92
- Conditions
- Primary Tooth Pulpotomy, Vital Pulp Therapy
- Keywords
- Primary Tooth, Pulpotomy, TheraCal PT, Biodentine, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NECIBE DAMLA ŞAHINUniversity, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Active comparator | Procedure: Biodentine PulpotomyPrimary 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. |
| LLLT + Biodentine | Experimental | Device: Low-Level Laser Therapy + BiodentinePrimary 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). |
| TheraCal PT | Experimental | Procedure: TheraCal PT PulpotomyPrimary 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. |
| LLLT + TheraCal PT | Experimental | Device: Low-Level Laser Therapy + TheraCal PTPrimary 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). |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodentine PulpotomyAlso: biomaterialAfter coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed. | Procedure or surgery | Biodentine |
| Low-Level Laser Therapy + BiodentineAlso: Laser and biomaterialAfter 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 | LLLT + Biodentine |
| TheraCal PT PulpotomyAfter coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed. | Procedure or surgery | TheraCal PT |
| Low-Level Laser Therapy + TheraCal PTFollowing 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 | LLLT + TheraCal PT |
Primary outcome
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.
2 secondary outcomes
Interim Clinical and Radiographic Success Rates
Time frame: 3 and 6 months after treatment
Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success
Time frame: 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Primary Tooth Pulpotomy
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
Pulpitis - Reversible, Pulpotomies on Primary Molars
Recruiting
Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
Pulpotomies Primary Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Necibe Damla ŞAHİN, DDS, PhD principal investigator
Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry, Tokat, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine Pulpotomy, Low-Level Laser Therapy + Biodentine and TheraCal PT Pulpotomy in people with Primary Tooth Pulpotomy and Vital Pulp Therapy, run by NECIBE DAMLA ŞAHIN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.