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

C

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

TheraCal
Experimental group
Description:
Indirect pulp capping with TheraCal
Treatment:
Other: TheraCal
Mineral trioxide aggregate (MTA)
Active Comparator group
Description:
Indirect pulp capping with MTA
Treatment:
Other: MTA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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