Clinical trial NCT03626740: Experimental Research on Deep Carious Lesion Treatment of Molars
Official title: Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: dental pulp
deep carious lesions
treatment effect
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pulpal survival rate
timeFrame: 20 months
Secondary outcomes:
measure: Incidence of apical root maturation (apexogenesis)
timeFrame: 20 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Division of Pedodontics, Faculty of Dental Medicine
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Andreea C Didilescu, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: