Dental Biofilm Control During Orthodontic Treatment

Gingivitis Clinical Trial

— ORTHOBIOFILM  

Official title:

Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532241
• Other study ID #: IP-2020-02-4027
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Rijeka
• Contact: Stjepan Spalj, PhD
• Phone: +385916119853
• Email: stjepan.spalj[@]fdmri.uniri.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Malocclusion

Intervention

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

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

Drug:
• Chlorhexidine mouthwash
0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

Locations

Country	Name	City	State
Croatia	University of Rijeka, Faculty of Dental Medicine	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University of Rijeka	University of Ljubljana

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   This research is a part of a larger project described on this site