Dental Caries, Pulpitis
Conditions
Keywords
Pulpotomy, Primary Molars, Calcium Silicate, Sodium Hypochlorite, Pediatric Dentistry, Vital Pulp Therapy
Brief summary
This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.
Detailed description
Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure. This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel). A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material. The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.
Interventions
Used as the capping agent after coronal pulp removal in primary molars.
DRUGBiodentine
Used as a bioactive pulpotomy agent following coronal pulp amputation.
DRUGFerric Sulfate
15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.
5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.
Sponsors
Inonu University
Sacide Duman
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to the treatment allocation to reduce assessment bias. Participants, care providers, and investigators are aware of the assigned treatments.
Intervention model description
This is a randomized controlled clinical trial with a split-mouth design where each participant receives multiple interventions on different teeth.
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Children aged between 4 and 7 years * At least one primary molar indicated for pulpotomy * No spontaneous pain or systemic infection * Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4) * Signed informed consent from parents or legal guardians
Exclusion criteria
* Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency) * Uncooperative behavior (Frankl rating 1 or 2) * Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown * History of allergy to any materials used in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinical success after pulpotomy in primary molars | 12 months after pulpotomy | Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with radiographic success after pulpotomy in primary molars | 12 months after pulpotomy | Radiographic success is defined as the absence of internal/external root resorption, periapical or furcal radiolucency, and periodontal ligament widening. |
Countries
Turkey (Türkiye)
Outcome results
None listed