Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars

Clinical and Radiographic Outcomes of Pulpotomy of Primary Molars Using Totalfill® Bioceramic Root Repair Material -Fast Set Putty, and ProRoot White MTA®. A Randomized Controlled Trial

An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.

Study Overview

• Status: Completed
• Conditions: Extensively Decayed Primary Molars
• Intervention / Treatment: Drug: Totalfill; Drug: MTA

Detailed Description

When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.

The participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.

After placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient inclusion criteria

   • ASA 1 patient, Patient is a completely healthy & fit. No allergy or medical conditions.
   • Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.
   • Parent agreed to participate in the study, and signed the written consent.
   • Patient attended the out-patients pediatric dental clinic in UZ Gent.

2. Tooth inclusion criteria 2.1. Clinical inclusion criteria:

   • Vital primary molars (first or second) with deep caries cavity with pulpal exposure.
   • Only mandibular primary molar were included
   • No spontaneous pain
   • No history of swelling
   • No sinus tract/ fistula
   • Absent of tenderness in percussion
   • No pathological mobility
   • Restorable tooth (stainless steel crown can be placed)
   • Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.

2.2. Radiographical inclusion criteria:

• At least 2/3rd of root is present
• Absence of internal or external root resorption
• Absence of pathologic root resorption
• Absence of periapical or furcation radiolucency

Exclusion Criteria:

If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Totalfill; Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy	Drug: Totalfill; Totalfill® Bioceramic Root Repair Material -Fast Set Putty is a pre-mixed, bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.; Other Names: Totalfill® Bioceramic Root Repair Material -Fast Set Putty
Active Comparator: MTA; ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy	Drug: MTA; ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.; Other Names: ProRoot White MTA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation	Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn & Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.	6 months follow-up
Clinical evaluation	Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn & Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.	12 months follow-up
Radiographic evaluation	Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn & Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.	6 months follow-up
Radiographic evaluation	Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn & Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed to place the material	To measure the time consumed to place each material and then to compare them if there is a significant difference. After removing the coronal pulp and achieving the hemostasis . The operator start the timer when he places the material till restoring the tooth with GIC.	Immediately after each intervention for a maximum of the intervention

Collaborators and Investigators

• Sponsor: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MTA; Primary molars; Pulpotomy; Bioceramics; Totalfill; Bioactive; calcium silicate cement
• Other Study ID Numbers: EC UZG 2016/0723 - 2016/0724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available in the literature in the manuscript after publication
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes