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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
80
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))
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
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
bacterial composition of dental biofilm
bacterial ratio in dental biofilm (molecular biology analysis)
Time frame: 90 days (change from start to 2 months and 3 months after start)
gingival enlargement
Seymour index (thickness (scale 0=normal-2=thickening \>=3mm) + proportion of tooth crown coverage (scale 0=normal-3=papilla involving .2/3 of adjacent tooth crown half) on frontal teeth vestibular and oral in both jaws; scale 0-100), higher score means worse outcome
Time frame: 90 days (change from start to 2 months and 3 months after start)
dental biofilm accumulation
Silness-Loe index and Williams modification for subjects in orthodontic treatment on a scale from 0=no biofilm to 3=a continuous line greater than 1mm, mean value of referent teeth, range 0-3, higher score indicates worse outcome
Time frame: 90 days (change from start to 2 months and 3 months after start)
pH of biofilm
colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity)
Time frame: 90 days (change from start to 2 months and 3 months after start)
extent of gingivitis
Full mouth bleeding score on a scale 0-100%, higher score means worse outcome
Time frame: 90 days (change from start to 2 months and 3 months after start)
oral health-related quality of life
Oral Health Impact Profile (modification for gingivitis), 8 items, each on a scale 0=never-4=very often, range 0-32, higher score means worse outcome
Time frame: 90 days (change from start to 2 months and 3 months after start)
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