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: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: TheraCal; Other: MTA

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Division of Pedodontics, Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	20 months

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy
• Investigators: Principal Investigator: Andreea C Didilescu, DDS, PhD, Carol Davila University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 4, 2020

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: dental pulp; treatment effect; deep carious lesions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No