Dental Biofilm Control During Orthodontic Treatment

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05532241
Study type	Interventional
Source	University of Rijeka
Contact	Stjepan Spalj, PhD
Phone	+385916119853
Email	stjepan.spalj@fdmri.uniri.hr
Status	Recruiting
Phase	Phase 3
Start date	November 1, 2021
Completion date	December 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dental Biofilm Control During Orthodontic Treatment — ORTHOBIOFILM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms