Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
TheraCal
MTA
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children focused on measuring dental pulp, deep carious lesions, treatment effect
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.
Sites / Locations
- Division of Pedodontics, Faculty of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TheraCal
Mineral trioxide aggregate (MTA)
Arm Description
Indirect pulp capping with TheraCal
Indirect pulp capping with MTA
Outcomes
Primary Outcome Measures
Clinical pulpal survival rate
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.
Secondary Outcome Measures
Incidence of apical root maturation (apexogenesis)
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).
Full Information
NCT ID
NCT03626740
First Posted
August 1, 2018
Last Updated
August 2, 2021
Sponsor
Carol Davila University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT03626740
Brief Title
Experimental Research on Deep Carious Lesion Treatment of Molars
Acronym
VITAPULP
Official Title
Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carol Davila University of Medicine and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
dental pulp, deep carious lesions, treatment effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TheraCal
Arm Type
Experimental
Arm Description
Indirect pulp capping with TheraCal
Arm Title
Mineral trioxide aggregate (MTA)
Arm Type
Active Comparator
Arm Description
Indirect pulp capping with MTA
Intervention Type
Other
Intervention Name(s)
TheraCal
Intervention Description
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal
Intervention Type
Other
Intervention Name(s)
MTA
Intervention Description
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA
Primary Outcome Measure Information:
Title
Clinical pulpal survival rate
Description
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.
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Incidence of apical root maturation (apexogenesis)
Description
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).
Time Frame
20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea C Didilescu, DDS, PhD
Organizational Affiliation
Carol Davila University of Medicine and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Pedodontics, Faculty of Dental Medicine
City
Bucharest
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Experimental Research on Deep Carious Lesion Treatment of Molars
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