Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)

Carol Davila University of Medicine and Pharmacy

Status

Completed

Conditions

Dental Caries in Children

Treatments

Other: TheraCal

Other: MTA

Study type

Interventional

Funder types

Other

Identifiers

NCT03626740

PN-III-P4-ID-PCE-2016-0506

Details and patient eligibility

About

Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.

In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.

Full description

Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.

MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.

TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.

Enrollment

40 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

untreated deep uncomplicated carious lesions in first permanent molars (FPM)
absence of clinical diagnosis of pulp exposure
fistula
swelling of periodontal tissues
abnormal tooth mobility
history of spontaneous pain or sensitivity to percussion
healthy appearance of adjacent gingiva
normal tooth color
positive vitality to thermal and electric tests.

Exclusion criteria

FPM with previous treatment
FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
children with mental disabilities or systemic diseases.