Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05532241
PHASE3

Dental Biofilm Control During Orthodontic Treatment

Sponsor: University of Rijeka

View on ClinicalTrials.gov

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.

Official title: Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

Key Details

Gender

All

Age Range

13 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-11-01

Completion Date

2026-06-01

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

DEVICE

fixed metal orthodontic appliance

fixed metal orthodontic appliance (stainless steel brackets (Mini Master MBT 0.022'', American Orthodontics), nickel-titanium archwire (NiTi, American Orthodontics), elastomeric ligatures (Elastomerics, American Orthodontics))

DEVICE

fixed non-metal orthodontic appliance

fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))

PROCEDURE

oral hygiene

conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)

DRUG

Chlorhexidine mouthwash

conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

Locations (3)

University of Rijeka Faculty of Dental Medicine

Rijeka, Croatia

University of Rijeka, Faculty od Dental Medicine, Dental Clinic

Rijeka, Croatia

University of Rijeka, Faculty of Dental Medicine

Rijeka, Croatia