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12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

Primary Purpose

Fluorosis, Oral Deseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resin infiltration
Microabrasion
Sponsored by
DMG Dental Material Gesellschaft mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluorosis focused on measuring Enamel defects, Fluorosis, Icon, Resin infiltration

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Resin infiltration

    Microabrasion

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Surface changes
    changes that occur on the surface of the teeth with fluorosis, which have been treated with DMG Icon ® and micro-abrasion assessed via photographs
    Clinical characteristics Icon
    clinical characteristics of the tooth surfaces that have been treated with DMG Icon ® and micro-abrasion and its relationship to the degree of fluorosis
    Efficacy of infiltration to mask fluorotic teeth long-time
    Compare the benefit of the infiltrative resin DMG Icon related to micro abrasion Opalustre ULTRADENT as control procedure, focus: stabilisation of masking quantified by photographs

    Full Information

    First Posted
    September 28, 2016
    Last Updated
    June 14, 2023
    Sponsor
    DMG Dental Material Gesellschaft mbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02925780
    Brief Title
    12 Month Follow up in Vivo Icon Study on Fluorotic Teeth
    Official Title
    In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Organisational and regulatory challenges.
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    DMG Dental Material Gesellschaft mbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.
    Detailed Description
    Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact. The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies. This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fluorosis, Oral Deseases
    Keywords
    Enamel defects, Fluorosis, Icon, Resin infiltration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Resin infiltration
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Microabrasion
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Resin infiltration
    Other Intervention Name(s)
    Icon (DMG, Germany), Approximal resin infiltration kit
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Microabrasion
    Other Intervention Name(s)
    Opalustre (Ultradent, USA)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel
    Description
    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
    Time Frame
    immediate after treatment
    Secondary Outcome Measure Information:
    Title
    Surface changes
    Description
    changes that occur on the surface of the teeth with fluorosis, which have been treated with DMG Icon ® and micro-abrasion assessed via photographs
    Time Frame
    12 month
    Title
    Clinical characteristics Icon
    Description
    clinical characteristics of the tooth surfaces that have been treated with DMG Icon ® and micro-abrasion and its relationship to the degree of fluorosis
    Time Frame
    3, 6, 9, 12 month
    Title
    Efficacy of infiltration to mask fluorotic teeth long-time
    Description
    Compare the benefit of the infiltrative resin DMG Icon related to micro abrasion Opalustre ULTRADENT as control procedure, focus: stabilisation of masking quantified by photographs
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Armas Vega
    Organizational Affiliation
    Universidad Internacional del Ecuador
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

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