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

NCT ID: NCT05149651

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Extensively Decayed Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Totalfill

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

Group Type EXPERIMENTAL

Totalfill

Intervention Type 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.

MTA

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

Group Type ACTIVE_COMPARATOR

MTA

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

MTA

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

Intervention Type DRUG

Other Intervention Names

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Totalfill® Bioceramic Root Repair Material -Fast Set Putty ProRoot White MTA®

Eligibility Criteria

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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.

* 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
* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC UZG 2016/0723 - 2016/0724

Identifier Type: -

Identifier Source: org_study_id