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Pulp Protection in Selective Carious Tissue Removal

NCT04250142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2022-12-28

No results posted yet for this study

Summary

Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. This double blinded randomized controlled clinical trial aims to analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. The study will include 142 restorations allocated to either experimental arm. After 12 and 24 months, restoration survival, pulp response and radiographic lesion progression will be assessed.

Conditions

  • Dental Caries

Interventions

DEVICE

Self-etching Adhesive

A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.

DEVICE

Glass Ionomer

A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.

Sponsors & Collaborators

  • University of Talca

    lead OTHER

Principal Investigators

  • Cecilia Muñoz Sandoval, DDS · University of Talca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2021-12-23
Completion
2022-03-18
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250142 on ClinicalTrials.gov