Dental Biofilm Control During Orthodontic Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

Conditions
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Gingivitis, Malocclusion

Intervention / Treatment
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* Device: fixed metal orthodontic appliance
* Device: fixed non-metal orthodontic appliance
* Procedure: oral hygiene
* Drug: Chlorhexidine mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 types of appliances and 2 experimental conditions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metal + OH<br>fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm) | Device: fixed metal orthodontic appliance<br>* 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))<br>Procedure: oral hygiene<br>* conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)<br>|
| Experimental: metal + CHX<br>fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate) | Device: fixed metal orthodontic appliance<br>* 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))<br>Drug: Chlorhexidine mouthwash<br>* 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month<br>|
| Placebo Comparator: non-metal + OH<br>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<br>* fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), nylon thread, elastomeric ligatures (Elastomerics, American Orthodontics))<br>Procedure: oral hygiene<br>* conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)<br>|
| Active Comparator: non-metal + CHX<br>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<br>* fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), nylon thread, elastomeric ligatures (Elastomerics, American Orthodontics))<br>Drug: Chlorhexidine mouthwash<br>* 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial composition of dental biofilm | bacterial ratio in dental biofilm (molecular biology analysis) | 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 | 90 days (change from start to 2 months and 3 months after start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 90 days (change from start to 2 months and 3 months after start) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malocclusion, gingivitis, dental biofilm