Gingivitis, Malocclusion
Conditions
Keywords
malocclusion, gingivitis, dental biofilm
Brief 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.
Detailed 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.
Interventions
DEVICEfixed 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))
DEVICEfixed non-metal orthodontic appliance
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))
PROCEDUREoral hygiene
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
DRUGChlorhexidine mouthwash
conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
Sponsors
University of Rijeka
University of Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Groups were labeled as I-IV, appliance is fixed on teeth and visible for both participants and care providers. Mouthwash is also visible. Outcome assessor does not know wether patient was in mouthwash group, but he sees the type of appliance. Microbiologist and statisticians are not aware of the group affiliation.
Intervention model description
2 types of appliances and 2 experimental conditions
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3)
Exclusion criteria
* neurodevelopmental disorders * intellectual disability * oligodontia * congenital craniofacial anomalies * orofacial clefts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gingival enlargement | 90 days (change from start to 2 months and 3 months after start) | 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 |
| bacterial composition of dental biofilm | 90 days (change from start to 2 months and 3 months after start) | bacterial ratio in dental biofilm (molecular biology analysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dental biofilm accumulation | 90 days (change from start to 2 months and 3 months after start) | 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 |
| pH of biofilm | 90 days (change from start to 2 months and 3 months after start) | colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity) |
| extent of gingivitis | 90 days (change from start to 2 months and 3 months after start) | Full mouth bleeding score on a scale 0-100%, higher score means worse outcome |
| oral health-related quality of life | 90 days (change from start to 2 months and 3 months after start) | 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 |
Countries
Croatia
Outcome results
None listed