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

University Ghent

Status and phase: Completed; Phase 4

Conditions: Extensively Decayed Primary Molars

Treatments: Drug: Totalfill; Drug: MTA

Study type: Interventional

Funder types: Other

Identifiers

NCT05149651

EC UZG 2016/0723 - 2016/0724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 2 patient groups

Totalfill

Experimental group

Description:

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

Treatment:

Drug: Totalfill

MTA

Active Comparator group

Description:

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

Treatment:

Drug: MTA