Experimental Research on Deep Carious Lesion Treatment of Molars

Dental Caries in Children Clinical Trial

— VITAPULP  

Official title:

Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626740
• Other study ID #: PN-III-P4-ID-PCE-2016-0506
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: October 4, 2020

Study information

• Verified date: August 2021
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 4, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• TheraCal
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal
• MTA
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA

Locations

Country	Name	City	State
Romania	Division of Pedodontics, Faculty of Dental Medicine	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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