Primary Tooth Pulpotomy, Vital Pulp Therapy
Conditions
Keywords
Primary Tooth, Pulpotomy, TheraCal PT, Biodentine, Low-Level Laser Therapy
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.
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.
Interventions
PROCEDUREBiodentine Pulpotomy
After coronal pulp removal, Biodentine (Septodont, France) was placed over the remaining pulp tissue. No laser application was performed.
DEVICELow-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).
PROCEDURETheraCal PT Pulpotomy
After coronal pulp removal, TheraCal PT (Bisco Inc., USA) was applied directly onto the pulp tissue. No laser application was performed.
DEVICELow-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).
Sponsors
Tokat Gaziosmanpasa University
NECIBE DAMLA ŞAHIN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars | 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
| Measure | Time frame | Description |
|---|---|---|
| Interim Clinical and Radiographic Success Rates | 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. |
| Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed