Comparative Clinical and Radiographic Evaluation of Different Pulpotomy Materials in Primary Molars

NCT07769697 | Completed

• 1 other identifier: 2021/161
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to four treatment groups. Clinical and radiographic evaluations were performed at 3, 6, 9, and 12 months to compare treatment success and failure among the four pulpotomy materials.

Conditions

Dental Caries; Pulp Exposure, Dental; Primary Teeth; Primary Molar Pulpotomy

Keywords

Primary teeth Pulpotomy; Primary Molars; Vital Pulp Therapy; Mineral Trioxide Aggregate; Calcium-Enriched Mixture; TheraCal PT; Ferric Sulfate

Outcome Measures

Primary Outcomes (2)

• Rate of clinical success at 12 months

  Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 12-month follow-up.

  12 months

• Rate of radiographic success at 12 months

  Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 12-month follow-up.

  12 months

Secondary Outcomes (14)

• Rate of clinical success at 3 months

  3 months

• Rate of clinical success at 6 months

  6 months

• Rate of clinical success at 9 months

  9 months

• Rate of radiographic success at 3 months

  3 months

• Rate of radiographic success at 6 months

  6 months

Study Arms (4)

MTA Pulpotomy

ACTIVE COMPARATOR

Mineral Trioxide Aggregate

Procedure: Pulpotomy; Other: Mineral Trioxide Aggregate (MTA)

CEM Pulpotomy

ACTIVE COMPARATOR

Calcium-Enriched Mixture (CEM)

Procedure: Pulpotomy; Other: Calcium-Enriched Mixture (CEM)

Ferric Sulfate Pulpotomy

ACTIVE COMPARATOR

Ferric Sulfate

Procedure: Pulpotomy; Other: Ferric Sulfate

TheraCal PT Pulpotomy

ACTIVE COMPARATOR

TheraCal PT

Procedure: Pulpotomy; Other: TheraCal PT

Interventions

Pulpotomy PROCEDURE

Pulpotomy is a vital pulp therapy procedure in which the coronal pulp tissue is removed while preserving the vitality of the radicular pulp. Following hemostasis, the assigned pulpotomy material was applied according to the study protocol before definitive restoration of the tooth.

CEM Pulpotomy; Ferric Sulfate Pulpotomy; MTA Pulpotomy; TheraCal PT Pulpotomy

Mineral Trioxide Aggregate (MTA) OTHER

Mineral trioxide aggregate (MTA) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

MTA Pulpotomy

Calcium-Enriched Mixture (CEM) OTHER

Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

CEM Pulpotomy

Ferric Sulfate OTHER

Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

Ferric Sulfate Pulpotomy

TheraCal PT OTHER

TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

TheraCal PT Pulpotomy

Eligibility Criteria

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

You may qualify if:

• Patient-related criteria
• Children aged 4-9 years.
• Healthy children with no systemic disease.
• No regular medication use.
• No known allergy to the study materials.
• Cooperative patients able to undergo dental treatment.
• Written informed consent obtained from the parent or legal guardian. Tooth-related criteria
• Restorable primary molars with deep carious lesions requiring pulpotomy.
• Clinical signs and symptoms consistent with reversible pulpitis (no spontaneous, lingering, or nocturnal pain).
• No tenderness to percussion or pathological mobility.
• No swelling or sinus tract associated with the study tooth.
• Hemostasis achieved within 5 minutes after coronal pulp amputation.
• No radiographic evidence of internal or external root resorption, furcation or periapical radiolucency, periodontal ligament widening, or pulp calcification.
• At least two-thirds of the root length remaining.

You may not qualify if:

• No pulp exposure or pulp exposure ≤1 mm after complete caries removal.
• Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation.
• Excessive pulpal bleeding that could not be controlled within 5 minutes.
• Presence of purulent exudate from the pulp.
• Loss of patient cooperation during treatment.
• Withdrawal of parental consent or inability to attend follow-up visits.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Battalgazi, Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries; Dental Pulp Exposure

Interventions

Pulpotomy; mineral trioxide aggregate; calcium-enriched mixture cement; ferric sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the distinct physical characteristics of the pulpotomy materials, the operator could not be blinded to treatment allocation. However, participants were unaware of the assigned material, and clinical and radiographic outcomes were independently assessed by two blinded outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants were randomly assigned to one of four parallel treatment groups according to the pulpotomy material used (ferric sulfate, MTA, CEM, or TheraCal PT). Clinical and radiographic outcomes were evaluated over a 12-month follow-up period.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 18, 2026
• Study Start: October 21, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: August 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months following publication and ending 5 years after publication.
• Access Criteria: Access will be provided to researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Shared data will be de-identified to protect participant confidentiality.

Locations

TU (1)