Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo

NCT01417832 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2011-08-16

No results posted yet for this study

Summary

The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.

Conditions

  • Dental Caries

Interventions

DRUG

Resin infiltration / adhesive

Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.

DRUG

Placebo

In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.

Sponsors & Collaborators

  • DMG, Germany

    collaborator UNKNOWN
  • Universidad El Bosque, Bogotá

    lead OTHER

Principal Investigators

  • Stefania Martignon, PhD · Universidad El Bosque, Bogotá, COlombia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Colombia

Study Locations

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Entities

Drugs

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 NCT01417832 on ClinicalTrials.gov