NCT06874062

Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate

Clinical and Radiographic Evaluation of the Success of Resin-Modified Calcium Silicate in Primary Tooth Pulpotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

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.

Detailed description

Tooth decay is a complex process of enamel demineralization and remineralization caused by organic acids produced by microorganisms in the dental plaque. When this balance shifts in favor of demineralization, caries formation occurs. Initially, decay begins with small surface roughness or subsurface demineralization, followed by cavitation and subsequent pulp involvement. Tooth decay, one of the most common chronic diseases in childhood, negatively impacts the quality of life when left untreated, leading to problems such as pain, abscess formation, tooth loss, nutritional deficiencies, and speech disorders. To prevent early loss of primary teeth and maintain the health of the oral and surrounding tissues, restorative or endodontic treatments are applied. Treatment methods for deep dentin caries in primary teeth include indirect pulp capping, direct pulp capping, and amputation, with amputation being the most commonly used vital pulp therapy. Amputation is indicated when the pulp is either healthy or reversibly damaged and shows no signs of pulp degeneration, and the pulp becomes exposed during caries removal due to decay or mechanical causes. The goal of treatment is to preserve the vitality of the radicular pulp, control pain and inflammation, and maintain the tooth until its physiological exfoliation time. The selection of appropriate materials and techniques for amputation therapy is of critical importance. Although several studies have investigated the success of amputation materials and techniques, the ideal amputation material has not yet been defined. The ideal material and technique should be bactericidal, harmless to the pulp and surrounding tissues, support the healing of the root pulp, and contribute to the preservation of remaining tissues without affecting physiological root resorption. Additionally, factors such as cost and ease of application should also be considered in material selection. Therefore, efforts to identify the ideal amputation material continue. The aim of this study is to evaluate the clinical and radiographic success of Theracal PT®, ProRoot® MTA, and Neoputty® MTA, and to examine the relationship between these outcomes and factors such as age, gender, the position of the tooth in the arch, and the presence of provoked pain prior to treatment. The following hypotheses were proposed in our study: Hypothesis 1: There is no difference in the 12-month clinical and radiographic success rates of primary tooth amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT®. Hypothesis 2: The 12-month clinical and radiographic success of amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT® is not influenced by age, gender, the position of the tooth in the arch, or the presence of provoked pain prior to treatment. This study was conducted in accordance with the Ataturk University Faculty of Medicine Ethics Committee approval (Date: 30.03.2023/ Session no:02/ Decision no:04) and guidelines of the Helsinki Declaration. The study was supported by the Scientific Research Projects Coordination Unit of Atatürk University under project number TDH-2023-13045. In this study, the teeth to be treated were randomly assigned using stratified randomization, ensuring an equal number of teeth in each study group. The research design was based on a parallel groups model. When multiple teeth from the same patient participated in the study, randomization was also applied for the other materials to be used. Patient selection, examination, treatment, and follow-up processes were carried out by a single researcher undergoing specialty training in the Department of Pediatric Dentistry.

Conditions

• Pulpotomy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-06-20
• Primary completion: 2024-10-01
• Completion: 2024-11-18
• First posted: 2025-03-13
• Last updated: 2025-03-18

Locations

1 site across 1 country: Turkey (Türkiye)