RecruitingACTRN12617000925347

Comparison of the oral microorganisms between patients being treated with orthodontic brackets or aligners.

Difference in the oral microbiota of patients being treated with clear aligners and brackets: a clinical trial

Sponsor

University of Melbourne, School of Dentistry

Enrollment

120 participants

Start Date

May 16, 2017

Study Type

Interventional

Conditions

Gingivitis White spot lesions

Summary

This research will compare the individual bacterial taxa between 2 orthodontic appliances, the fixed self-ligating bracket system and Invisalign clear aligners. The association of individual taxa and the presence or absence of white spot lesions and gingivitis for both orthodontic techniques will be analysed.

Eligibility

Sex: Both males and femalesMin Age: 11 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing the bacteria in the mouths of people wearing two different types of orthodontic (braces) devices: traditional metal brackets (fixed braces) and Invisalign clear plastic aligners. Researchers want to know if one type of brace leads to more harmful bacteria that could cause white spots on teeth or gum inflammation. Understanding this can help orthodontists and patients make more informed choices. You may be eligible if: - You are 11 years old or older - You have less than 8mm of teeth crowding - All your permanent teeth are present (except wisdom teeth and any needed for orthodontic treatment) - You have good oral hygiene and no immediate need for dental fillings - Your teeth and gums are healthy at the start of the study You may NOT be eligible if: - You have a significant jaw alignment problem (ANB below or equal to 5 degrees) - You have a large bite discrepancy (CR-CO discrepancy greater than 3mm) - You have an open bite (front or back) - You are pregnant, diabetic, using mouth rinses, or taking medications including antibiotics - You have impacted teeth, pre-existing white spots on teeth, or enamel defects - You have active gum disease with attachment loss Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Clear orthodontic aligners (Invisalign) to move teeth. Test subjects- 60 participants will be treated orthodontically using Invisalign aligners. The aligners are to be worn 22 hours per day. Plaque

Clear orthodontic aligners (Invisalign) to move teeth. Test subjects- 60 participants will be treated orthodontically using Invisalign aligners. The aligners are to be worn 22 hours per day. Plaque samples will be taken and analysed prior to the start of treatment and at 6 months of treatment. Presence of white spot tooth lesions and gingivitis will be assessed at these 2 time periods. The aligners will be prescribed and inserted by orthodontic postgraduate students under the supervision of fully qualified orthodontic specialists, or by orthodontists at private orthodontic practices.