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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000925347
Enrollment
116
Registered
2017-06-27
Start date
2017-05-16
Completion date
2019-10-01
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 f

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.

Sponsors

University of Melbourne, School of Dentistry
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
11 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1) There is less than 8mm of crowding. 2) Patients have all permanent teeth present, except third molars and any necessary orthodontic extractions. 3) Demonstrate ability to maintain adequate oral hygiene. 4) Show optimum dental health without the immediate need for restorations.

Exclusion criteria

1) Skeletal anterior-posterior discrepancies between the maxilla and mandible (ANB below or equal to 5). 2) Centric relation (CR)- Centric occlusion (CO) discrepancies of greater than 3mm. 3) Anterior or posterior open bite. 4) Patients who are pregnant, diabetic, using mouth rinses or taking medications, including antibiotic therapy. 5) Presence of impacted teeth. 6) Presence of pre-treatment white spot lesions. 7) Presence of developmental defects of enamel i.e. Amelogenesis imperfecta, hypomineralisation. 8) Presence of active periodontal disease as evidenced by attachment loss.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026