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Completed

NCT Number: NCT05149651

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

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.

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Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Treatment and study plan

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.

Other names: Totalfill® Bioceramic Root Repair Material -Fast Set Putty

MTA

Drug

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®

Primary outcomes

  1. Clinical evaluation

    Time frame: 6 months follow-up

    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.

  2. Clinical evaluation

    Time frame: 12 months follow-up

    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.

  3. Radiographic evaluation

    Time frame: 6 months follow-up

    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.

  4. Radiographic evaluation

    Time frame: 12 months follow-up

    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.

Secondary outcomes

  1. Time needed to place the material

    Time frame: Immediately after each intervention for a maximum of the intervention

    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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 8, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.