Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07548008

Enrollment

Registered

2026-04-23

Start date

2025-08-10

Completion date

2027-02-10

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Pulpotomies Primary Teeth

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 9 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical and Radiographic Success Rate of Pulpotomy	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

Measure	Time frame	Description
Clinical Success Rate	6, 12, and 24 months	Evaluation of clinical success based on absence of pain, mobility, fistula, abscess, and tenderness.
Radiographic Success Rate	6, 12, and 24 months	Evaluation of radiographic success based on absence of pathological findings such as resorption and radiolucency.

Countries

Turkey (Türkiye)

Outcome results