12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

NCT ID: NCT02925780

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Fluorosis; Oral Deseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resin infiltration

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.

Group Type: EXPERIMENTAL

Resin infiltration

Intervention Type: 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).

Microabrasion

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.

Group Type: ACTIVE_COMPARATOR

Microabrasion

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Icon (DMG, Germany), Approximal resin infiltration kit; Opalustre (Ultradent, USA)

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DMG Dental Material Gesellschaft mbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Armas Vega

Role: PRINCIPAL_INVESTIGATOR

Universidad Internacional del Ecuador

Other Identifiers

RIAFLUOR

Identifier Type: -

Identifier Source: org_study_id