Trials / Completed
CompletedNCT03626740
Experimental Research on Deep Carious Lesion Treatment of Molars
Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Carol Davila University of Medicine and Pharmacy · Academic / Other
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | TheraCal | Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal |
| OTHER | MTA | Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA |
Timeline
- Start date
- 2018-01-08
- Primary completion
- 2020-06-30
- Completion
- 2020-10-04
- First posted
- 2018-08-13
- Last updated
- 2021-08-06
Locations
1 site across 1 country: Romania
Source: ClinicalTrials.gov record NCT03626740. Inclusion in this directory is not an endorsement.