NCT05213650: İnvisalign

Cleaning Agents Impact on Invisalign Aligners: A Cross-Over Randomized Trial

Completed NA Last updated 27 July 2023

What this trial tests

NA trial testing non-abrasive toothpaste in Aligner Staining in 20 participants. Completed in 1 December 2022.

Timeline

18 October 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Bezmialem Vakif University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	20
Start date	18 October 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• non-abrasive toothpaste
• abrasive toothpaste
• Efferdent
• Cleaning Crystals

Conditions studied

• Aligner Staining — all drugs for Aligner Staining →

Sponsor

Bezmialem Vakif University

Who can join

Adults 7 to 70, any sex, with Aligner Staining. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Today, the increasing aesthetic expectations of the patients, showing its effect in the field of orthodontics, leads to the orientation towards aesthetic materials. The Invisalign system is also polyurethane for aesthetic purposes.

It is a series of transparent plaques personalized to the patient's problems. However, the transparent structure of the plaque increases the importance of its cleanliness.

There are many studies evaluating the removal of bacterial biofilm from plaques. However There are minimal studies evaluating the effect of the materials used for cleaning on the light transmittance, which has a significant effect on the aesthetics of the plaques.

The aim of this study is to compare 5 different agents' effects on colour change.

The work created will be divided into 5 groups according to the cleaning materials used.

One of the cleaning agents will be assigned by lot and will be used while the treatment processes are continuing.

The colour measurement will be carried out using the VITA Easyshade Compact spectrophotometer (VITA Zahnfabrik DEASYC220, Bad Sackingen, Germany). To prevent external light interference and keep the measurement head in a fixed position for each measurement, a special cubic box with a 3 mm radius entrance was created. The head of the device was firmly attached to the box lid with black tape to increase light-tightness. The colour measurement will be performed from the occlusal region of the second premolar tooth on the aligners, which will be placed on a standard white background. The colour measurement will be carried out as received and after the aligners were used in the patient's mouth for 2 weeks. Prior to measurements, the spectrophotometer will be calibrated according to the manufacturer's instructions. Each measurement will be repeated three times, and the average value will be determined. The Commision de l'Eclairage (CIE) Lab\* system will be used for colour measurements. This system uses three parameters to define colour. The L\* coordinate is a brightness measure that ranges from 0 (black) to 100 (white); the a\* coordinate is horizontal and shows chromatic coordinates between red (+) and green (-), and the b\* coordinate is also horizontal and extends in the direction of yellow (b+) and blue (b-). To determine the colour difference, a formula (Formula 1) will be used. ∆L, ∆a, and ∆b values will be calculated by subtracting the starting measurements (L0, a0, b0) from the final measurements (L1, a1, b1). The ∆E value will be calculated using these values, and the colour difference between groups will be compared.

∆E2-1 = \[(∆L)2 + (+ (∆a)2 + (∆b)2\]1/2= \[(L1-L0)2 + (a1-a0)2 + (b1-b0)2\]1/2 The formula proposed by Filho and da Silva will be used to convert ΔE values to National Bureau of Standards (NBS) values. NBS unit = ΔE\* × 0.92. The ΔE values will be converted to their clinical significance using the NBS system.

According to the results of the research, the colour change of the agents used to clean Invisalign aligners will be determined.

The use of agents that have a minor effect on aesthetics can be considered ideal according to the results of the study

Publications & conference data

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

1. Comparative evaluation of the effect of different cleaning agents on colour and surface roughness of Invisalign clear aligners: a cross-over randomized controlled trial.
   Kılıç B, Canpolat Ş, Öztürk M. · · 2025 · PMID 41188779 · DOI 10.1186/s12903-025-06928-w