Ferric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth

NCT07548008 | Active Not Recruiting

• 2 other identifiers: 2025-08Ethics Committee
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Pulpotomies Primary Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Success Rate

  6, 12, and 24 months

• Radiographic Success Rate

  6, 12, and 24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28292337 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: August 10, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)