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12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

NCT02925780 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-18

No results posted yet for this study

Summary

Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

Conditions

  • Fluorosis
  • Oral Deseases

Interventions

DEVICE

Resin infiltration

Teeth selected for this group will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, teeth will be isolated with a rubber dam and the labial tooth surface cleaned with non-fluoride prophylactic paste and pumice. After an etching and drying step (to open the lesion surface), Icon will be applied following the manufacturer's instructions and subsequently light cured, followed by polishing. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).

DEVICE

Microabrasion

The labial surfaces of teeth selected for this group will be isolated and precleaned. Subsequently, the microabrasive material, Opalustre, will be applied according to the manufacturer's instructions, using a rubber cup at low speed (5 times each for 5 seconds). Between each of the applications the surface is washed by flushing water using a syringe. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).

Sponsors & Collaborators

  • DMG Dental Material Gesellschaft mbH

    lead INDUSTRY

Principal Investigators

  • Ana Armas Vega · Universidad Internacional del Ecuador

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-06-30
Completion
2021-12-31

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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 NCT02925780 on ClinicalTrials.gov