Pulpotomy Materials in Primary Molars

Sacide Duman

Status: Completed

Conditions: Dental Caries; Pulpitis

Treatments: Drug: Ferric Sulfate; Drug: Sodium hypochlorite gel application; Drug: Mineral Trioxide Aggregate (MTA); Drug: Biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT07120321

TSA-2021-2486. (Other Grant/Funding Number)

2021/77-INUDF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 4 patient groups

MTA Group

Experimental group

Description:

Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament.

Treatment:

Drug: Mineral Trioxide Aggregate (MTA)

Biodentine Group

Experimental group

Description:

Primary molars treated with Biodentine as the pulpotomy medicament.

Treatment:

Drug: Biodentine

Ferric Sulfate Group

Experimental group

Description:

Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament.

Treatment:

Drug: Ferric Sulfate

Sodium Hypochlorite Gel Group

Experimental group

Description:

Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament.

Treatment:

Drug: Sodium hypochlorite gel application