Overview

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

Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Ghent
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.