İnvisalign: Comparison of Light Transmittance of Invisalign Plates Cleaned Using Different Cleaning Agents

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05213650
Collaborator
(none)
20
1
5
13.4
1.5

Study Details

Study Description

Brief Summary

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 according 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 very limited 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 studyis to compare 5 different agents effects on light permeability.

The work created will be divided into 5 different 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.

Plates collected from patients, LEDEX

™ cm 4000 radiometer (Dentmate Technology Co., Ltd. New Taipei City 24872, Taiwan, M443509, M452752) will determine the light transmittance and compare 5 groups with each other.

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

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

Condition or Disease Intervention/Treatment Phase
  • Other: non-abrasive toothpaste
  • Other: abrasive toothpaste
  • Other: Efferdent
  • Other: Cleaning Crystals
N/A

Detailed Description

In recent years, following the developments in the field of orthodontics, the participation and expectations of patients in treatment have also changed. Conventional orthodontic brackets may cause aesthetic concerns in patients. The use of aesthetic materials and techniques aimed at overcoming such limitations has increased.

An orthodontic treatment system made with a material made of polyurethane was introduced for the first time in 1998 as an alternative to conventional brackets. This system uses CAD/CAM technology to produce serial plates personalized to the treatment process.

It is very important to clean these appliances for aesthetic reasons and to prevent bacteria from accumulating and becoming a focus of infection for the oral cavity. If plaques are not cleaned regularly, they can act as a reservoir for bacteria, leading to periodontal diseases, cavities and bad breath.

In the treatment of clear plaque, the patient is asked not to eat or drink anything other than water while the plaques are in the mouth. However, despite all the recommendations, patients sometimes do not comply with these and may consume coloring drinks while the plaques are in their mouths. This situation causes changes in the polymer of the material and adversely affects the aesthetics, which is the main advantage of clear aligner treatment.

Color stability and light transmittance of clear aligners remain critical considerations for both patients and clinicians. Despite the increasing cost, patients' desire for transparent aligners is due to the fact that these plates have almost no transparency in the mouth, so maintaining light permeability is an important issue.

Although there are many studies in the literature evaluating the removal of bacterial biofilm after cleaning of clear plaques, there are very limited studies evaluating the light transmittance of plaques.

In the light of this information, the aim of this research is to evaluate the light transmittance of transparent plaques, which is a polyurethane material, using 5 different cleaning methods. The cleaning methods to be used for this; toothpaste, whitening toothpaste, Corega Pro Guard & Retainer cleaning tablet, Efferdent antibacterial cleaning tablet and liquid soap.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
controlled clinical trialcontrolled clinical trial
Masking:
Single (Participant)
Masking Description:
It will be shared with the participants of the study that when their treatment is finished, the plaques will be requested back and a study will be carried out on these plaques to affect the plaques from the process. However, the information that the study is on the effects of the cleaning agent they use will not be shared. Therefore, the participants do not have information about being in a group related to plaque cleaning efficiency.
Primary Purpose:
Diagnostic
Official Title:
Comparison of Light Transmittance of Invisalign Plates Cleaned Using Different Cleaning Agents
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Invisalign control patients (liquid soap)

Patients who clean their plaques only with liquid soap and toothbrush

Experimental: Invisalign non-abrasive toothpaste patients

Patients who clean their plaque with non-abrasive toothpaste and toothbrush

Other: non-abrasive toothpaste
Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Non-abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.
Other Names:
  • cleaning agent
  • Experimental: Invisalign abrasive toothpaste patients

    Patients who clean their plaque with abrasive toothpaste and toothbrush

    Other: abrasive toothpaste
    Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.
    Other Names:
  • cleaning agent
  • Experimental: Invisalign Efferdent patients

    Patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week

    Other: Efferdent
    Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water.The Efferdent tablet will be used once a week as an intervention to aligner cleaning during invisalign treatment.
    Other Names:
  • cleaning agent
  • Experimental: Invisalign Cleaning Crystals patients

    Patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week

    Other: Cleaning Crystals
    Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Invisalign Cleaning Crystals will be used once a week as an intervention to aligner cleaning during invisalign treatment.
    Other Names:
  • cleaning agent
  • Outcome Measures

    Primary Outcome Measures

    1. light transmittance change (mW/cm²)_control [1 week]

      light transmittance change of 12 clear aligners of patients who clean their plaques only with liquid soap and a toothbrush

    2. light transmittance change (mW/cm²)_Invisalign non-abrasive toothpaste patients [1 week]

      light transmittance change of 12 clear aligners of patients who clean their plaques with non-abrasive toothpaste and toothbrush

    3. light transmittance change (mW/cm²)_ Invisalign abrasive toothpaste patients [1 week]

      light transmittance change of 12 clear aligners of patients who clean their plaque with abrasive toothpaste and toothbrush

    4. light transmittance change (mW/cm²)_Invisalign Efferdent patients [1 week]

      light transmittance change of 12 clear aligners of patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week

    5. light transmittance change (mW/cm²)_Invisalign Cleaning Crystals patients [1 week]

      light transmittance change of 12 clear aligners of patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion criteria for the study:
    1. No active periodontal disease

    2. No caries

    3. No systemic disease

    4. Patients who do not use any medication will be included in the study.

    5. Patients who will use more than 20 transparent plates in their treatment-

    Exclusion Criteria:
    1. Smoking (more than 1 pack per day)

    2. Patients consuming dyes such as coffee, tea, beer and red wine more than 2 times a day

    3. Patients using less than 20 clear plates in their treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banu Kılıç Fatih İstanbul Turkey 34093

    Sponsors and Collaborators

    • Bezmialem Vakif University

    Investigators

    • Study Director: Banu Kılıç, Bezmialem Vakıf Üniversitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Banu Kılıç, Assistant Professor, Bezmialem Vakif University
    ClinicalTrials.gov Identifier:
    NCT05213650
    Other Study ID Numbers:
    • BezmialemVU invisalign
    First Posted:
    Jan 28, 2022
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022