Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth

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.

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Key information

Conditions

Dental Caries Pulpotomies Primary Teeth Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Clinical and Radiographic Success Rate of Pulpotomy

Time frame: 24 months

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.

Secondary outcomes

Clinical Success Rate

Time frame: 6, 12, and 24 months

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

Time frame: 6, 12, and 24 months

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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of the Clinical and Radiographic Outcomes of Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Apr 23, 2026
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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