Clinical trial

Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

Name

IP-2020-02-4027

Description

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.

Trial arms

Trial start

2021-11-01

Estimated PCD

2024-11-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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))

Arms:

metal + CHX, metal + OH

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))

Arms:

non-metal + CHX, non-metal + OH

oral hygiene

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

Arms:

metal + OH, non-metal + OH

Chlorhexidine mouthwash

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

Arms:

metal + CHX, non-metal + CHX

Size

120

Primary endpoint

bacterial composition of dental biofilm

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

gingival enlargement

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 types of appliances and 2 experimental conditions', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Groups were labeled as I-IV, appliance is fixed on teeth and visible for both participants and care providers. Mouthwash is also visible. Outcome assessor does not know wether patient was in mouthwash group, but he sees the type of appliance. Microbiologist and statisticians are not aware of the group affiliation.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

Organization

University of Rijeka