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Microbiome and Immunogenity of Saliva During Orthodontic Therapy

NCT04139538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-23

No results posted yet for this study

Summary

There are two essential ways of treatment in the field of orthodontics. The fixed appliance treatment with self-ligating or conventional brackets and treatment with aligners. Fixed orthodontic treatment has been the optional therapy for decades. Due to an increasing demand of patients for a more aesthetic treatment, the number of aligner treatments multiplied over the last years. Within the last years, a crucial role of oral microbiome in the maintenance of oral health was largely appreciated. However, to date there is no data on the effect of different orthodontic treatments on the oral microbiome. The aim of the research project is the prospective comparison of the oral microbiome in saliva of adult patients treated with Invisalign® aligners or metal brackets. We plan to include a sample of twenty healthy individuals. Half of the participants will receive aligner treatment with Invisalign® and half metal brackets. Saliva will be collected before, 3 and 6 months after the beginning of the orthodontic therapy via a stimulated a saliva collection. The 16S rDNA genes will be amplified and sequenced with Illumina MiSeq® System. Probing depth, bleeding on probing and Plaque Index will be evaluated over time and correlated with changes of the oral microbiome.

Conditions

  • Orthodontic Appliances, Removable
  • Orthodontic Appliances, Fixed
  • Oral Microbiome
  • Cell Culture
  • Periodontal Index

Interventions

PROCEDURE

orthodontic treatment

Malocclusion will be treated with orthodontic appliances (fixed or removable)

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-09-01
Completion
2024-10-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139538 on ClinicalTrials.gov