Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626740
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Andreea Didilescu, DDS, Carol Davila University of Medicine and Pharmacy

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Dental Caries in Children Other: TheraCal Other: MTA Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : October 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TheraCal
Indirect pulp capping with TheraCal
 Other: 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
 Other: MTA
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626740


Locations
Layout table for location information
Romania
Division of Pedodontics, Faculty of Dental Medicine
Bucharest, Romania
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
Investigators
Layout table for investigator information
Principal Investigator: Andreea C Didilescu, DDS, PhD Carol Davila University of Medicine and Pharmacy
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Andreea Didilescu, DDS, Vice dean for Research, Professor, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03626740    
Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0506
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreea Didilescu, DDS, Carol Davila University of Medicine and Pharmacy:
dental pulp
deep carious lesions
treatment effect
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases