Experimental Research on Deep Carious Lesion Treatment of Molars

NCT03626740 | Completed DMC

• 1 other identifier: PN-III-P4-ID-PCE-2016-0506
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Keywords

dental pulp; deep carious lesions; treatment effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of apical root maturation (apexogenesis)

  20 months

Study Arms (2)

TheraCal

EXPERIMENTAL

Indirect pulp capping with TheraCal

Other: TheraCal

Mineral trioxide aggregate (MTA)

ACTIVE COMPARATOR

Indirect pulp capping with MTA

Other: MTA

Interventions

TheraCal OTHER

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

TheraCal

MTA OTHER

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

Mineral trioxide aggregate (MTA)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• FPM with previous treatment
• FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
• children with mental disabilities or systemic diseases.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Division of Pedodontics, Faculty of Dental Medicine

Bucharest, Romania

Location

MeSH Terms

Interventions

TheraCal; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Andreea C Didilescu, DDS, PhD

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice dean for Research, Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 13, 2018
• Study Start: January 8, 2018
• Primary Completion: June 30, 2020
• Study Completion: October 4, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)