Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)
|ClinicalTrials.gov Identifier: NCT03626740|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : January 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Other: TheraCal Other: MTA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||April 2021|
Indirect pulp capping with TheraCal
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal
Active Comparator: Mineral trioxide aggregate (MTA)
Indirect pulp capping with MTA
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA
- Clinical pulpal survival rate [ Time Frame: 20 months ]Pulpal survival is defined by positive response without lingering sensation to the cold test, absence of clinical signs and symptoms, and no apical radiolucency on the periapical radiograph.
- Incidence of apical root maturation (apexogenesis) [ Time Frame: 20 months ]We will investigate the treatment effect on apexogenesis in children who had incomplete root formation at the beginning of the study and preserve their pulp vitality at the end of the study. The outcome will be compared radiographically with apical maturation in molar pairs (healthy contralateral molar, where applicable).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626740
|Division of Pedodontics, Faculty of Dental Medicine|
|Principal Investigator:||Andreea C Didilescu, DDS, PhD||Carol Davila University of Medicine and Pharmacy|