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Dental Biofilm Control During Orthodontic Treatment

Study acronym: ORTHOBIOFILM
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 1, 2025 to Jun 1, 2026
    • Site details revised at 3 of 3 sites
    v5
  2. Enrollment target: 120 to 80
    • Primary completion date: Nov 1, 2024 to May 1, 2025
    • Study sites: 1 to 3
    • Study completion date: Dec 1, 2024 to Jun 1, 2025
    v4
  3. Primary completion date: Feb 1, 2024 to Nov 1, 2024
    • Study completion date: Mar 1, 2024 to Dec 1, 2024
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05532241
Lead Sponsor University of Rijeka
Collaborators: University of Ljubljana
Conditions
(from sponsor)		 Gingivitis, Malocclusion
Related terms Gingivitis, Malocclusion
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov