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

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 Overview

• Status: Active, not recruiting
• Conditions: Dental Caries; Pulpotomies Primary Teeth

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged 4-9 years who were treated at the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry. These participants had previously undergone pulpotomy treatment in vital primary molars using either ferric sulfate or sodium hypochlorite as part of routine clinical care.

The study includes patients with available clinical records and diagnostic radiographs, and who are followed during routine recall visits at 6, 12, and 24 months. No additional interventions are performed as part of the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ferric Sulfate Group; Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate as part of routine clinical care.
Sodium Hypochlorite Group; Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 5% sodium hypochlorite as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marmara University

Publications and helpful links

General Publications

• Coll JA, Seale NS, Vargas K, Marghalani AA, Al Shamali S, Graham L. Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis. Pediatr Dent. 2017 Jan 15;39(1):16-123.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 2025-08; Ethics Committee (Other Identifier: Marmara University Faculty of Dentistry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves pediatric participants, and all data are anonymized and handled in accordance with ethical guidelines and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No