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Dental Biofilm Control During Orthodontic Treatment

NCT05532241 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-30

No results posted yet for this 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.

Conditions

  • Gingivitis
  • Malocclusion

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

Sponsors & Collaborators

  • University of Ljubljana

    collaborator OTHER

  • University of Rijeka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-05-01
Completion
2026-06-01

Countries

  • Croatia

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 NCT05532241 on ClinicalTrials.gov