- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03626740
Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)
Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bucharest, Romania
- Division of Pedodontics, Faculty of Dental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TheraCal
Indirect pulp capping with TheraCal
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
20 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andreea C Didilescu, DDS, PhD, Carol Davila University of Medicine and Pharmacy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PN-III-P4-ID-PCE-2016-0506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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