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NCT Number: NCT07120321

Pulpotomy Materials in Primary Molars

This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.

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Key information

Conditions

Dental Caries Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry

Malatya, 44280, Turkey (Türkiye)

About this study

Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure.

This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel).

A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material.

The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged between 4 and 7 years
  • At least one primary molar indicated for pulpotomy
  • No spontaneous pain or systemic infection
  • Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4)
  • Signed informed consent from parents or legal guardians

Exclusion criteria

  • Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency)
  • Uncooperative behavior (Frankl rating 1 or 2)
  • Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown
  • History of allergy to any materials used in the study

Treatment and study plan

Mineral Trioxide Aggregate (MTA)

Drug

Used as the capping agent after coronal pulp removal in primary molars.

Other names: MTA; ProRoot MTA

Biodentine

Drug

Used as a bioactive pulpotomy agent following coronal pulp amputation.

Other names: Septodont Biodentine; Calcium Silicate Cement

Ferric Sulfate

Drug

15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.

Other names: Astringedent; FS

Sodium hypochlorite gel application

Drug

5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.

Other names: NaOCl gel; Hypochlorite gel

Primary outcomes

  1. Number of participants with clinical success after pulpotomy in primary molars

    Time frame: 12 months after pulpotomy

    Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.

Secondary outcomes

  1. Number of participants with radiographic success after pulpotomy in primary molars

    Time frame: 12 months after pulpotomy

    Radiographic success is defined as the absence of internal/external root resorption, periapical or furcal radiolucency, and periodontal ligament widening.

Sponsors and collaborators

Lead sponsor

Sacide Duman

Other

Collaborators

  • Inonu University

Registry information

Official study title

Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

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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