Cleaning Agents Impact on Invisalign Aligners: A Cross-Over Randomized Trial
Condition: Aligner Staining
Study type: Interventional

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 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
    

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 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 the
      original colour of the aligners 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 Colour change
      of plaques.

      In the light of this information, the aim of this research is to evaluate the colour change
      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.
    

Intervention name(s): non-abrasive toothpaste; abrasive toothpaste; Efferdent; Cleaning Crystals
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; 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.; 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.; 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 intervention name(s): cleaning agent; cleaning agent; cleaning agent; cleaning agent
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: controlled clinical trial
Masking: Single (Participant)
Primary purpose: Diagnostic