Ghent University hospital
Ghent, 9000, Belgium
NCT Number: NCT05149651
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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Notify Me3 year–9 year
All sexes
Interventional
Phase 4
Ghent, 9000, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2.2. Radiographical inclusion criteria:
Exclusion criteria
If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.
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
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®
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.
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.
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.
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.
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.
University Ghent
Other
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
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