Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing

Summary

The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study.

Conditions

• Dental Malocclusion

Interventions

OTHER

Aligners cleansing with water

The product is masked in a spraying bottle without any labels. Once a day, for 14 days, the patient sprays the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.

OTHER

Aligners cleansing with dish soap Svelto

the product is masked in a transparent bottle without any labels. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.

OTHER

Aligners cleansing with Polident Antibacterial Denture Cleaner

the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the tablet in a glass full of warm water (30-35 °C), then the aligner is placed inside it for 5 minutes. Afterward the aligner is rinsed under fresh running water.

OTHER

Aligners cleansing with Invisalign Cleaning Crystals

the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the crystals in a glass full of warm water (30-35 °C) mixing with a spoon for 20 seconds; then, the aligner is placed inside the glass for 15 minutes. Afterward, the aligner is rinsed under fresh running water.

OTHER

Aligners cleansing with Geldis

the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.

Sponsors & Collaborators

• University of Pavia

  lead OTHER

Principal Investigators

• Andrea Scribante, DDS, PhD · University of Pavia

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2024-07-28

Completion

2024-07-30

Countries

• Italy

Study Locations