Microbiome and Immunogenity of Saliva During Orthodontic Therapy

NCT04139538 | Unknown

• 1 other identifier: 1288/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• changes of oral microbiome

  bacteria of the oral microbiome including cariogenic bacteria via dna sequencing

  up to 6 months

• changes of periodontal parameters

  plaque index

  up to 6 months

• changes of periodontal parameters

  probing depth

  up to 6 months

• changes of periodontal parameters

  bleeding on probing

  up to 6 months

Secondary Outcomes (2)

• immunogenity of saliva on oral cells in vitro

  up to 2 weeks

• immunogenity of saliva on oral cells in vitro

  up to 2 weeks

Study Arms (2)

Invisalign treatment

EXPERIMENTAL

Aligner patients will be treated with Invisalign® aligners to correct malocclusion

Procedure: orthodontic treatment

selfligating bracket treatment

ACTIVE COMPARATOR

Multibracket patients will be treated with self ligating orthodontic brackets

Procedure: orthodontic treatment

Interventions

orthodontic treatment PROCEDURE

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

Invisalign treatment; selfligating bracket treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Class I skeletal relationship
• Normo-divergent Frankfort Mandibular-Plane Angle
• Minimal mandibular crowding in range from 1 to 3 according to Little's Index (Little 1975)

You may not qualify if:

• Smoking habit
• Presence of extensive dental restorations in proximity to the gingival margin
• Presence of fixed bridges/crowns or partial dentures
• Previous periodontal nonsurgical treatment (such as full mouth disinfection, quadrant-by-quadrant therapy, full mouth debridement) within the past year
• Medications such as antibiotics, steroids, or nonsteroidal anti-inflammatory drugs within the past 6 months.
• Plaque Index \> 20% before start of treatment Diabetes Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (7)

• Klindworth A, Pruesse E, Schweer T, Peplies J, Quast C, Horn M, Glockner FO. Evaluation of general 16S ribosomal RNA gene PCR primers for classical and next-generation sequencing-based diversity studies. Nucleic Acids Res. 2013 Jan 7;41(1):e1. doi: 10.1093/nar/gks808. Epub 2012 Aug 28.

  PMID: 22933715 BACKGROUND

• Edgar RC. UPARSE: highly accurate OTU sequences from microbial amplicon reads. Nat Methods. 2013 Oct;10(10):996-8. doi: 10.1038/nmeth.2604. Epub 2013 Aug 18.

  PMID: 23955772 BACKGROUND

• Levrini L, Mangano A, Montanari P, Margherini S, Caprioglio A, Abbate GM. Periodontal health status in patients treated with the Invisalign((R)) system and fixed orthodontic appliances: A 3 months clinical and microbiological evaluation. Eur J Dent. 2015 Jul-Sep;9(3):404-410. doi: 10.4103/1305-7456.163218.

  PMID: 26430371 BACKGROUND

• Demling A, Demling C, Schwestka-Polly R, Stiesch M, Heuer W. Short-term influence of lingual orthodontic therapy on microbial parameters and periodontal status. A preliminary study. Angle Orthod. 2010 May;80(3):480-4. doi: 10.2319/061109-330.1.

  PMID: 20050740 BACKGROUND

• de Freitas AR, Silva TSO, Ribeiro RF, de Albuquerque Junior RF, Pedrazzi V, do Nascimento C. Oral bacterial colonization on dental implants restored with titanium or zirconia abutments: 6-month follow-up. Clin Oral Investig. 2018 Jul;22(6):2335-2343. doi: 10.1007/s00784-018-2334-0. Epub 2018 Jan 18.

  PMID: 29349504 BACKGROUND

• Haririan H, Andrukhov O, Bertl K, Lettner S, Kierstein S, Moritz A, Rausch-Fan X. Microbial analysis of subgingival plaque samples compared to that of whole saliva in patients with periodontitis. J Periodontol. 2014 Jun;85(6):819-28. doi: 10.1902/jop.2013.130306. Epub 2013 Oct 21.

  PMID: 24144271 BACKGROUND

• Ren Y, Vissink A. Cytokines in crevicular fluid and orthodontic tooth movement. Eur J Oral Sci. 2008 Apr;116(2):89-97. doi: 10.1111/j.1600-0722.2007.00511.x.

  PMID: 18353001 BACKGROUND

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff member, dentist

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: October 25, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)