Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate

NCT06874062 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/257
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pulpotomy; mineral trioxide aggregate; resin-modified calcium silicate cement

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  No spontaneous, provoked (developing due to a stimulus) or night pain complaints. No sensitivity to percussion or palpation. No pathological mobility in the tooth. No abscess or fistula in the tooth. If any of these findings are detected, the treatment is considered clinically unsuccessful.

  1 Month - 1 Year

• Radiographic Success

  No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space. If any of these findings are detected, the treatment is considered radiographically unsuccessful.

  3 Month - 1 Year

Secondary Outcomes (4)

• The Impact of Patient's Age on 12-Month Radiographic Success of Treatment.

  From treatment to the end of 12 months

• The Impact of Patient's Gender on 12-Month Radiographic Success of Treatment.

  From treatment to the end of 12 months

• The Impact of Tooth Position in the Dental Arch on the 12-Month Radiographic Success of Treatment

  From treatment to the end of 12 months

• The Impact of Pre-Treatment Provoked Pain on the 12-Month Radiographic Success of Treatment.

  From treatment to the end of 12 months

Study Arms (3)

NeoPutty MTA

EXPERIMENTAL

A ready-to-use putty-form Neoputty® MTA with a minimum piston length of 1.5 mm was placed on the pulp chamber floor using a sterile dental spatula. The material was adapted to the canal orifices with the aid of a cotton pellet that had been lightly moistened with sterile saline.

Procedure: Neoputty MTA Pulpotomy Treatment; Procedure: Stainless Steel Crown Application

ProRoot MTA

EXPERIMENTAL

Using a sterile glass and spatula, an adequate amount of powder and liquid was mixed for approximately 1 minute until a homogeneous consistency was achieved, following the manufacturer's recommendations. The ProRoot® MTA, prepared to a putty-like consistency, was transferred to the pulp chamber using a sterile dental spatula and adapted to the canal orifices with the aid of a cotton pellet.

Procedure: ProRoot MTA Pulpotomy Treatment; Procedure: Stainless Steel Crown Application

Theracal PT

EXPERIMENTAL

The TheraCal PT® package contains a 4 g tube and 10 single-use mixing tips. One of the disposable mixing tips was attached to the tube, and the material was mixed within the tip by pressing the plunger. The material was then directly applied to the pulp chamber. Adaptation of the material to the canal orifices was verified using a sterile cement applicator. Polymerization was performed for 10 seconds using a Woodpecker LED B (Guilin Woodpecker Medical Instrument Co., Ltd., China) curing light device, following the manufacturer's instructions.

Procedure: Theracal PT Pulpotomy Treatment; Procedure: Stainless Steel Crown Application

Interventions

Neoputty MTA Pulpotomy Treatment PROCEDURE

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.

NeoPutty MTA

ProRoot MTA Pulpotomy Treatment PROCEDURE

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.

ProRoot MTA

Theracal PT Pulpotomy Treatment PROCEDURE

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.

Theracal PT

Stainless Steel Crown Application PROCEDURE

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).

NeoPutty MTA; ProRoot MTA; Theracal PT

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Deep dentin caries,
• Lamina dura and periodontal interval can be observed normally,
• /3 of the root length is present,
• The permanent tooth germ below is present and its position is normal,
• If there is a history of provoked pain (the type of pain that goes away when the stimulus is removed),
• If there is a history of pain (short-term provoked pain, the pain goes away when the stimulus is removed,
• Teeth with mechanical perforation larger than a needle tip in the perforation area or perforated with caries,
• Teeth with light-colored bleeding and easily controlled within 3-5 minutes,
• Teeth that can be restored with PÇK were included in the study

You may not qualify if:

• Lesions in the inter-root and periapical region,
• Pathological external or internal root resorption,
• Canal calcification,
• Deformities such as taurodontism,
• Spontaneous pain or night pain,
• Structural anomalies,
• Abscess, swelling or fistula,
• Pathological mobility,
• Sensitivity to palpation and percussion,
• Infraocclusion,
• Dark, intense bleeding in the canal orifices

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (4)

• Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.

  PMID: 34321144 BACKGROUND

• Waterhouse P. Are different pulp treatment techniques and associated medicaments effective for the treatment of extensive decay in primary teeth? Evid Based Dent. 2021 Jan;22(1):12-13. doi: 10.1038/s41432-021-0162-6.

  PMID: 33772121 BACKGROUND

• Celik B, Atac AS, Cehreli ZC, Uysal S. A randomized trial of mineral trioxide aggregate cements in primary tooth pulpotomies. J Dent Child (Chic). 2013 Sep-Dec;80(3):126-32.

  PMID: 24351693 BACKGROUND

• Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.

  PMID: 36890738 BACKGROUND

Study Officials

• Fatih Şengül, Phd

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: June 20, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 18, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)