Experimental Research on Deep Carious Lesion Treatment of Molars

Not Applicable

Completed

• Conditions: Dental Caries in Children
• Interventions: Other: MTA; Other: TheraCal

• Registration Number: NCT03626740
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

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.

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-10-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral trioxide aggregate (MTA)	MTA	Indirect pulp capping with MTA
TheraCal	TheraCal	Indirect pulp capping with TheraCal

Primary Outcome Measures

Name	Time	Method
Clinical pulpal survival rate	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

Name	Time	Method
Incidence of apical root maturation (apexogenesis)	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).

Trial Locations

Locations (1)

Division of Pedodontics, Faculty of Dental Medicine; 🇷🇴 Bucharest, Romania