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

NCT05149651 | Completed Phase 4

• 1 other identifier: EC UZG 2016/0723 - 2016/0724
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extensively Decayed Primary Molars

Keywords

Totalfill; MTA; Bioactive; calcium silicate cement; Pulpotomy; Primary molars; Bioceramics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Time needed to place the material

  Immediately after each intervention for a maximum of the intervention

Study Arms (2)

Totalfill

EXPERIMENTAL

Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy

Drug: Totalfill

MTA

ACTIVE COMPARATOR

ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy

Drug: MTA

Interventions

Totalfill DRUG

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.

Also known as: Totalfill® Bioceramic Root Repair Material -Fast Set Putty

Totalfill

MTA DRUG

ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.

Also known as: ProRoot White MTA®

MTA

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• At least 2/3rd of root is present
• Absence of internal or external root resorption

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The included teeth were assigned randomly into two groups (Totalfill or MTA) using randomized sequences generated by the computer using Random Integer Generator (RANDOM.ORG, Randomness and Integrity Services Ltd.). The allocation ratio to the groups was set to be equal. To ensure double blinding at both patients and evaluators level during treatment, the type of material was concealed from the patient, and the patient had no information which material was used. In addition, the type of material was not mentioned in the patient file. Instead, it was replaced by a 4 digit code. The operators were also blinded for the type of material during the whole procedure starting from tooth preparation till the hemostasis was achieved and then were only informed at the time of material placement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: December 8, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication

Locations

BE (1)