Pulpotomy Materials in Primary Molars

N/ACompletedNCT07120321

Sacide Duman22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries Pulpitis

Interventions

Mineral Trioxide Aggregate (MTA)DRUG

Used as the capping agent after coronal pulp removal in primary molars.

BiodentineDRUG

Used as a bioactive pulpotomy agent following coronal pulp amputation.

Ferric SulfateDRUG

15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry

Malatya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Number of participants with clinical success after pulpotomy in primary molars

Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.

Time frame: 12 months after pulpotomy

Secondary Outcomes

Number of participants with radiographic success after pulpotomy in primary molars

Radiographic success is defined as the absence of internal/external root resorption, periapical or furcal radiolucency, and periodontal ligament widening.

Time frame: 12 months after pulpotomy

Data from ClinicalTrials.gov

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