Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth

N/AActive Not RecruitingNCT07548008

Marmara University56 enrolled

Overview

This study aims to compare the clinical and radiographic success of two commonly used pulpotomy agents, ferric sulfate (FS) and sodium hypochlorite (NaOCl), in vital primary molars. Pulpotomy is a widely used vital pulp therapy procedure in pediatric dentistry to preserve primary teeth until their natural exfoliation. The study will include children aged 4-9 years who previously received pulpotomy treatment using either FS or NaOCl at Marmara University Faculty of Dentistry. No additional treatment will be performed as part of this study. Patients will be followed during routine clinical visits at 6, 12, and 24 months. Clinical outcomes such as pain, mobility, and infection, as well as radiographic findings including resorption and radiolucency, will be evaluated. The results of this study are expected to provide evidence for the effectiveness of these materials and support clinical decision-making in pediatric dental practice.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dental Caries Pulpotomies Primary Teeth

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged 4-9 years * Patients who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate or 5% sodium hypochlorite between January and April 2025 Availability of preoperative diagnostic periapical radiographs of adequate quality * Complete clinical records of the pulpotomy procedure * Patients who attended or agreed to attend follow-up visits at 6, 12, and 24 months * Cases in which the treatment protocol and materials used were clearly documented Exclusion Criteria: * Incomplete or poor-quality clinical and/or radiographic records * Presence of systemic diseases (e.g., immunosuppression, uncontrolled systemic conditions) * History of allergy or hypersensitivity to ferric sulfate or sodium hypochlorite * Teeth with intraoperative complications (e.g., perforation, uncontrolled bleeding, or change in treatment plan) * Teeth with pulp exposure due to trauma (only caries-related cases included) * Patients who did not attend follow-up visits or attended only one follow-up visit

Outcomes

Primary Outcomes

Clinical and Radiographic Success Rate of Pulpotomy

The primary outcome is the clinical and radiographic success of pulpotomy-treated primary teeth. Clinical success is defined as the absence of pain, mobility, fistula, abscess, or tenderness to percussion. Radiographic success is defined as the absence of internal or external resorption, periapical or furcal radiolucency, and other pathological findings.

Time frame: 24 months

Secondary Outcomes

Clinical Success Rate

Evaluation of clinical success based on absence of pain, mobility, fistula, abscess, and tenderness.

Time frame: 6, 12, and 24 months

Radiographic Success Rate

Evaluation of radiographic success based on absence of pathological findings such as resorption and radiolucency.