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

Phase 4

Completed

• Conditions: Extensively Decayed Primary Molars
• Interventions: Drug: Totalfill; Drug: MTA

• Registration Number: NCT05149651
• Lead Sponsor: University Ghent

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.

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-05-11
• Primary Completion: 2018-12-31
• Study Completion: 2020-12-31
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Totalfill	Totalfill	Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy
MTA	MTA	ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy

Primary Outcome Measures

Name	Time	Method
Clinical evaluation	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.
Radiographic evaluation	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 Outcome Measures

Name	Time	Method
Time needed to place the material	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.

Trial Locations

Locations (1)

Ghent University hospital; 🇧🇪 Ghent, Belgium