Pulpotomy Materials in Primary Molars

NCT07120321 | Completed

• 2 other identifiers: 2021/77-INUDFTSA-2021-2486.
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries; Pulpitis

Keywords

Pulpotomy; Primary Molars; Calcium Silicate; Sodium Hypochlorite; Pediatric Dentistry; Vital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with clinical success after pulpotomy in primary molars

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

  12 months after pulpotomy

Secondary Outcomes (1)

• Number of participants with radiographic success after pulpotomy in primary molars

  12 months after pulpotomy

Study Arms (4)

MTA Group

EXPERIMENTAL

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

Drug: Mineral Trioxide Aggregate (MTA)

Biodentine Group

EXPERIMENTAL

Primary molars treated with Biodentine as the pulpotomy medicament.

Drug: Biodentine

Ferric Sulfate Group

EXPERIMENTAL

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

Drug: Ferric Sulfate

Sodium Hypochlorite Gel Group

EXPERIMENTAL

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

Drug: Sodium hypochlorite gel application

Interventions

Mineral Trioxide Aggregate (MTA) DRUG

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

Also known as: MTA; ProRoot MTA

MTA Group

Biodentine DRUG

Used as a bioactive pulpotomy agent following coronal pulp amputation.

Also known as: Septodont Biodentine; Calcium Silicate Cement

Biodentine Group

Ferric Sulfate DRUG

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

Also known as: Astringedent; FS

Ferric Sulfate Group

Sodium hypochlorite gel application DRUG

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

Also known as: NaOCl gel; Hypochlorite gel

Sodium Hypochlorite Gel Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sacide Duman: lead
• Inonu University: collaborator

Study Sites (1)

Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

• Vural H, Senem Ozsunkar P, Duman S, Syed AZ, Tirasci G. Clinical and radiographic outcomes of four pulpotomy agents in primary molars: a prospective randomized controlled trial. Odontology. 2025 Dec 7. doi: 10.1007/s10266-025-01281-4. Online ahead of print.

  PMID: 41353690 DERIVED

MeSH Terms

Conditions

Dental Caries; Pulpitis

Interventions

mineral trioxide aggregate; ProRoot MTA; tricalcium silicate; ferric sulfate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Pulp Diseases

Study Officials

• sacide duman, Assoc Prof

  Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to the treatment allocation to reduce assessment bias. Participants, care providers, and investigators are aware of the assigned treatments.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: This is a randomized controlled clinical trial with a split-mouth design where each participant receives multiple interventions on different teeth.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 13, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)