Dental Biofilm Control During Orthodontic Treatment (ORTHOBIOFILM)

University of Rijeka

Status and phase: Active, not recruiting; Phase 3

Conditions: Malocclusion; Gingivitis

Treatments: Device: fixed metal orthodontic appliance; Procedure: oral hygiene; Device: fixed non-metal orthodontic appliance; Drug: Chlorhexidine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT05532241

IP-2020-02-4027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

metal + OH

Experimental group

Description:

fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)

Treatment:

Procedure: oral hygiene

Device: fixed metal orthodontic appliance

metal + CHX

Experimental group

Description:

fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)

Treatment:

Drug: Chlorhexidine mouthwash

Device: fixed metal orthodontic appliance

non-metal + OH

Placebo Comparator group

Description:

fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)

Treatment:

Device: fixed non-metal orthodontic appliance

Procedure: oral hygiene

non-metal + CHX

Active Comparator group

Description:

fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)

Treatment:

Drug: Chlorhexidine mouthwash

Device: fixed non-metal orthodontic appliance