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

NCT06278116 | Completed

• 1 other identifier: 2024-ALIGNERSCLEANSIGN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

clear aligners

Outcome Measures

Primary Outcomes (2)

• Change in adsorbance (A) value

  The changes in adsorbance values evaluated with a spectrophotometer.

  Baseline (T0) and after 14 days from baseline (T1)

• Changes in patient's perception

  Through a questionnaire, a subjective evaluation is carried out as regards: * the patient's perception of the ease of use of the five products; * the difference perceived by the patient in terms of subjective changes in color, smell, taste, cleanness and tactile sensation after the first use, after a week and after 2 weeks of the cleaning method. For each of the 19 questions, a mark from 0 (worse mark) to 10 (best mark) will be provided.

  Baseline (T0) and after 14 days from baseline (T1)

Secondary Outcomes (6)

• Changes in Probing Pocket Depth (PPD) values

  Baseline (T0) and after 14 days from baseline (T1)

• Changes in Gingival Index (GI) values

  Baseline (T0) and after 14 days from baseline (T1)

• Changes in Bleeding on probing (BOP)

  Baseline (T0) and after 14 days from baseline (T1)

• Change in Schiff Air Index - Dental sensitivity test

  Baseline (T0) and after 14 days from baseline (T1)

• Change of the BEWE Index Basic Erosive Wear Examination

  Baseline (T0) and after 14 days from baseline (T1)

Study Arms (5)

Water

ACTIVE COMPARATOR

Other: Aligners cleansing with water

Dish soap

ACTIVE COMPARATOR

Other: Aligners cleansing with dish soap Svelto

Polident Antibacterial Denture Cleaner®

ACTIVE COMPARATOR

Other: Aligners cleansing with Polident Antibacterial Denture Cleaner

Invisalign Cleaning Crystals®

ACTIVE COMPARATOR

Other: Aligners cleansing with Invisalign Cleaning Crystals

Geldis®

ACTIVE COMPARATOR

Other: Aligners cleansing with Geldis

Interventions

Aligners cleansing with dish soap Svelto OTHER

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.

Dish soap

Aligners cleansing with water OTHER

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.

Water

Aligners cleansing with Polident Antibacterial Denture Cleaner OTHER

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.

Polident Antibacterial Denture Cleaner®

Aligners cleansing with Invisalign Cleaning Crystals OTHER

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.

Invisalign Cleaning Crystals®

Aligners cleansing with Geldis OTHER

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.

Geldis®

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing orthodontic treatment with Invisalign® clear aligners.

You may not qualify if:

• Failing to follow cleaning method instructions
• Failing to fill in the questionnaires

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Water

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: July 28, 2024
• Study Completion: July 30, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)