12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

NCT02925780 | Withdrawn

• 1 other identifier: RIAFLUOR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fluorosis; Oral Deseases

Keywords

Enamel defects; Fluorosis; Icon; Resin infiltration

Outcome Measures

Primary Outcomes (1)

• action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel

  Evaluate the action of DMG Icon-infiltrative resin and micro abrasion immediately after application to mask fluorotic teeth by comparison of pre- vs. post-treatment photographs

  immediate after treatment

Secondary Outcomes (3)

• Surface changes

  12 month

• Clinical characteristics Icon

  3, 6, 9, 12 month

• Efficacy of infiltration to mask fluorotic teeth long-time

  12 month

Study Arms (2)

Resin infiltration

EXPERIMENTAL

The labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated using the resin infiltrant "Icon" (DMG, Germany). This is a minimally invasive treatment to improve the aesthetics by masking the white spots.

Device: Resin infiltration

Microabrasion

ACTIVE COMPARATOR

The labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated by microabrasion using the microabrasive material "Opalustre" (Ultradent, USA). This is a minimally invasive treatment to improve the aesthetics by masking the white spots.

Device: Microabrasion

Interventions

Resin infiltration DEVICE

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).

Also known as: Icon (DMG, Germany), Approximal resin infiltration kit

Resin infiltration

Microabrasion DEVICE

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).

Also known as: Opalustre (Ultradent, USA)

Microabrasion

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth.
• Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups.

You may not qualify if:

• Teeth without fluorosis.
• Teeth with hypoplasia.
• Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque.
• Teeth previously restored or with aesthetic corrective treatments
• Teeth with endodontic treatment.
• Patients with low or questionable hygiene.
• Malnourished patients or that have some underlying disease.
• Teeth with less than two thirds of its visible crown.
• Children that have less than six teeth in their oral cavity.
• Allergic reaction to methylmethacrylate.

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead

MeSH Terms

Conditions

Fluoride Poisoning

Interventions

Enamel Microabrasion

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• Ana Armas Vega

  Universidad Internacional del Ecuador

  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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: December 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share