Clinical trial NCT05149651: Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Extensively Decayed Primary Molars
Keywords: Totalfill
MTA
Bioactive
calcium silicate cement
Pulpotomy
Primary molars
Bioceramics
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical evaluation
timeFrame: 6 months follow-up
measure: Clinical evaluation
timeFrame: 12 months follow-up
measure: Radiographic evaluation
timeFrame: 6 months follow-up
measure: Radiographic evaluation
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Time needed to place the material
timeFrame: Immediately after each intervention for a maximum of the intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University hospital
Study officials:
References: