NCT05532241

Dental Biofilm Control During Orthodontic Treatment

Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Rijeka · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gingivitis
• Malocclusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-05-01
• Completion: 2026-06-01
• First posted: 2022-09-08
• Last updated: 2026-01-30

Locations

3 sites across 1 country: Croatia