Skip to main content
OpenTrials
Completed

NCT Number: NCT03626740

Experimental Research on Deep Carious Lesion Treatment of Molars

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Pedodontics, Faculty of Dental Medicine

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TheraCal

Other

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal

MTA

Other

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: VITAPULP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.