Dental Biofilm Control During Orthodontic Treatment

Last updated: January 28, 2026
Sponsor: University of Rijeka
Overall Status: Active - Not Recruiting

Phase

3

Condition

Periodontitis

Treatment

fixed metal orthodontic appliance

oral hygiene

Chlorhexidine mouthwash

Clinical Study ID

NCT05532241
IP-2020-02-4027
  • Ages 13-18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • malocclusion with moderate or great need for orthodontic treatment (Index ofOrthodontic Treatment Need grades >=3)

Exclusion

Exclusion Criteria:

  • neurodevelopmental disorders

  • intellectual disability

  • oligodontia

  • congenital craniofacial anomalies

  • orofacial clefts

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: fixed metal orthodontic appliance
Phase: 3
Study Start date:
November 01, 2021
Estimated Completion Date:
June 01, 2026

Study Description

The aim is:

  • to determine the clinical characteristics of gingiva of subjects not exposed to metals of dental alloys and exposed to metals

  • characterization of microbiome of dental biofilm in subjects not exposed to metals of dental alloys and exposed to metals and to determine changes in the structure of dental biofilm due to exposure to metals

  • examine the extent to which environmental influences modify the effectiveness of treatment of gingivitis by mechanical removal of biofilm and chemical control (chlorhexidine digluconate mouthwash (CHX))

  • to examine the behavior of bacteria of early and late colonizers of dental biofilm after chemical control

  • to analyze biofilm on metal and non-metal appliance

  • to explore patient reported outcome measures Study design is a randomized controlled trial with 4 parallel groups: (I) fixed metal orthodontic appliance with regular oral hygiene, (II) fixed metal orthodontic appliance with CHX, (III) non-metal fixed orthodontic appliance with regular oral hygiene, and (IV) non-metal orthodontic appliance with CHX.

Connect with a study center

  • University of Rijeka Faculty of Dental Medicine

    Rijeka, 51000
    Croatia

    Site Not Available

  • University of Rijeka, Faculty od Dental Medicine, Dental Clinic

    Rijeka, 51000
    Croatia

    Active - Recruiting

  • University of Rijeka, Faculty of Dental Medicine

    Rijeka, 51000
    Croatia

    Active - Recruiting

  • University of Rijeka Faculty of Dental Medicine

    Rijeka 3191648, 51000
    Croatia

    Site Not Available

  • University of Rijeka, Faculty od Dental Medicine, Dental Clinic

    Rijeka 3191648, 51000
    Croatia

    Site Not Available

  • University of Rijeka, Faculty of Dental Medicine

    Rijeka 3191648, 51000
    Croatia

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.