A Phase 3 interventional study of fixed metal orthodontic appliance and fixed non-metal orthodontic appliance in Gingivitis and Malocclusion, sponsored by University of Rijeka. Active, not recruiting at 3 sites in Croatia. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by University of Rijeka · Phase 3, Interventional, and Supportive care
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:
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's planned enrollment of 80 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Rijeka is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Device: fixed metal orthodontic appliance · Procedure: oral hygiene
fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Device: fixed metal orthodontic appliance · Drug: Chlorhexidine mouthwash
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Device: fixed non-metal orthodontic appliance · Procedure: oral hygiene
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Device: fixed non-metal orthodontic appliance · Drug: Chlorhexidine mouthwash
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))
Also known as: Mini Master MBT 0.022'' and nickel-titanium archwire (American Orthodontics)
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))
Also known as: Radiance MBT 0.022'' (American Orthodontics) and polyamide thread
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
Also known as: Parodontax (GSK)
conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
Also known as: Parodontax (GSK) + Curasept ADS 212 (Curadent)
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)
Plan to share: Yes — Individual participant data will be shared on reasonable request.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Rijeka