Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate

Summary

The goal of this clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). The main questions this study aims to answer are: Is Theracal PT as effective as MTA, the gold standard for pulpotomy treatment? Is Neoputty MTA, which is easier to handle, more effective than ProRoot MTA? The study will include systemically healthy children aged 4 to 9 years with at least one primary molar requiring pulpotomy. Treated teeth will be evaluated clinically and radiographically at 3, 6, and 12 months.

Conditions

• Pulpotomy

Interventions

PROCEDURE

Neoputty MTA Pulpotomy Treatment

All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Neoputty MTA was placed.

PROCEDURE

ProRoot MTA Pulpotomy Treatment

All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, ProRoot MTA was placed.

PROCEDURE

Theracal PT Pulpotomy Treatment

All caries were removed before entering the pulp chamber. Once all caries were removed, a carbide bur was used under copious water spray to expose the pulp chamber.Coronal pulp is removed with a round bur on a slow speed handpiece. Hemostasis was achieved by applying a cotton pellet moistened with sterile saline for no more than 5 minutes. After achieving hemostasis, Theracal PT was placed.

PROCEDURE

Stainless Steel Crown Application

After pulpotomy treatment, the pulpotomy material was covered using a capsule-form glass ionomer (EQUIA Forte®, GC, Tokyo, Japan). In the same session, preparation was performed for the placement of a stainless steel crown (SSC), and an appropriately sized SSC (3M ESPE, Seefeld, Germany) was selected based on visual estimation. After trial fitting on the tooth, the crown was cemented using a capsule-form glass ionomer (Riva, SDI Ltd., Victoria, Australia).

Sponsors & Collaborators

• Ataturk University

  lead OTHER

Principal Investigators

• Fatih Şengül, Phd · Ataturk University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2024-10-01

Completion

2024-11-18

Countries

• Turkey (Türkiye)

Study Locations