Dental Biofilm Control During Orthodontic Treatment
- Conditions
- GingivitisMalocclusion
- Interventions
- Device: fixed metal orthodontic applianceDevice: fixed non-metal orthodontic applianceProcedure: oral hygiene
- Registration Number
- NCT05532241
- Lead Sponsor
- University of Rijeka
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades >=3)
- neurodevelopmental disorders
- intellectual disability
- oligodontia
- congenital craniofacial anomalies
- orofacial clefts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description metal + OH fixed metal orthodontic appliance fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm) metal + OH oral hygiene fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm) metal + CHX fixed metal orthodontic appliance fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate) metal + CHX Chlorhexidine mouthwash fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate) non-metal + OH fixed non-metal orthodontic appliance fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm) non-metal + OH oral hygiene fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm) non-metal + CHX fixed non-metal orthodontic appliance fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate) non-metal + CHX Chlorhexidine mouthwash fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
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
Trial Locations
- Locations (3)
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