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NCT Number: NCT05532241

Dental Biofilm Control During Orthodontic Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gingivitis Gingival Diseases Infections Malocclusion Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fixed metal orthodontic appliance

Device

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))

Other names: Mini Master MBT 0.022'' and nickel-titanium archwire (American Orthodontics)

fixed non-metal orthodontic appliance

Device

fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))

Other names: Radiance MBT 0.022'' (American Orthodontics) and polyamide thread

oral hygiene

Procedure

conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)

Other names: Parodontax (GSK)

Chlorhexidine mouthwash

Drug

conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

Other names: Parodontax (GSK) + Curasept ADS 212 (Curadent)

Primary outcomes

  1. bacterial composition of dental biofilm

    Time frame: 90 days (change from start to 2 months and 3 months after start)

    bacterial ratio in dental biofilm (molecular biology analysis)

  2. gingival enlargement

    Time frame: 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

Secondary outcomes

  1. dental biofilm accumulation

    Time frame: 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

  2. pH of biofilm

    Time frame: 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)

  3. extent of gingivitis

    Time frame: 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

  4. oral health-related quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Collaborators

  • University of Ljubljana

Registry information

Official study title

Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

Acronym: ORTHOBIOFILM

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 8, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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