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

Study Overview
=================
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.

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

Conditions
-----------------
Extensively Decayed Primary Molars

Intervention / Treatment
-----------------
* Drug: Totalfill
* Drug: MTA


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Totalfill<br>Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy | Drug: Totalfill<br>* 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.<br>* Other names: Totalfill® Bioceramic Root Repair Material -Fast Set Putty;|
| Active Comparator: MTA<br>ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy | Drug: MTA<br>* ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.<br>* Other names: ProRoot White MTA®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation | 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. | 6 months follow-up | 
| Clinical evaluation | 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. | 12 months follow-up | 
| Radiographic evaluation | 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. | 6 months follow-up | 
| Radiographic evaluation | 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. | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to place the material | 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. | Immediately after each intervention for a maximum of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Totalfill, MTA, Bioactive, calcium silicate cement, Pulpotomy, Primary molars, Bioceramics