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Clinical Trial Proximal Caries Infiltration and Detection

NCT01796106 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-19

Study results available
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Summary

The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions in primary molars over 24 months. In addition, this study will assess the use of a scanning fiber endoscope (SFE) laser optical device for the assessment of caries lesions and their progression in comparison to radiographic examination.

A total of 50 participants (age 6-13 years) with at least 1 proximal early caries lesion will be enrolled. The participants will be followed up at 12 and 24 months. Lesion status will be monitored through radiographic and SFE laser optical device imaging.

Conditions

  • Caries,Dental

Interventions

DEVICE

Resin infiltration

Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth, the study lesions will be treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions. Essentially, the treatment consists of the following parts: 1) isolating the tooth with a rubber dam and cleaning its surface; 2) removing/ conditioning the surface layer of the lesion (using Icon-Etch) to open the lesion body; 3) drying of the exposed porous enamel; 4) infiltrating the existing pore volume with the resin infiltrant (Icon Infiltrant); 5) light curing of the resin infiltrant; 6) repeating the infiltration step including light curing; followed by 7) finalizing using interproximal finishing/polishing strips.

DEVICE

Fluoride varnish & Oral hygiene instruction

Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy will be provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) will be used according to manufactures´ instructions.

Sponsors & Collaborators

  • DMG Dental Material Gesellschaft mbH

    lead INDUSTRY

Principal Investigators

  • Joel Berg, DDS, MS · The Center for Pediatric Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

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 NCT01796106 on ClinicalTrials.gov