NCT06259214

Aesthetic Efficacy of Resin Infiltration Using Different Conditioning Methods: 24-Month Results

Completed NA Last updated 14 February 2024

What this trial tests

NA trial testing 15% HCl gel in White Spot Lesion in 30 participants. Completed in 6 April 2020.

Timeline

6 January 2017

Primary endpoint
6 January 2019

6 April 2020

Quick facts

Lead sponsor	Ondokuz Mayıs University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	6 January 2017
Primary completion	6 January 2019
Estimated completion	6 April 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• 15% HCl gel
• H3PO4 gel
• Er:YAG laser

Conditions studied

• White Spot Lesion — all drugs for White Spot Lesion →

Sponsor

Ondokuz Mayıs University

Who can join

Adults 15 to 19, any sex, with White Spot Lesion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: To assess color and fluorescence changes in white spot lesions (WSLs) using different surface conditioning methods prior to resin infiltration: 24-months follow-up Methods: Thirty patients with each at minimum four WSLs after bracket debonding were included. After baseline fluorescence and color measurements, the lesions were randomly divided into four groups (n = 30): G1 (control): regular brushing, G2: 15% HCl gel (Icon Etch), G3: 37% H3PO4 gel (Scotchbond Etchant), G4: Er:YAG laser (Fotona AT Fidelis III). The lesions were desiccated with Icon Dry and then Icon Infiltrant (DMG) was applied. In the treatment groups, color and fluorescence were examined at baseline (T0), just after the resin infiltration treatment (T1), and after 6 (T2) and 24 months (T3). In the control group, the examinations were performed at baseline (T0) and after 6 (T2) and 24 months (T3).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Aesthetic efficacy of resin infiltration on post-orthodontic white spot lesions using different conditioning methods: 24-month randomized control follow-up.
   Karaman E, Alan Unsal K, Oz AZ, Oz AA, et al · · 2026 · PMID 41672455 · DOI 10.2319/022825-165.1