Clinical trial NCT05532241: Dental Biofilm Control During Orthodontic Treatment
Official title: Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gingivitis
Malocclusion
Keywords: malocclusion
gingivitis
dental biofilm
Lead sponsor: University of Rijeka
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2022-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 types of appliances and 2 experimental conditions
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: bacterial composition of dental biofilm
timeFrame: 90 days (change from start to 2 months and 3 months after start)
measure: gingival enlargement
timeFrame: 90 days (change from start to 2 months and 3 months after start)
Secondary outcomes:
measure: dental biofilm accumulation
timeFrame: 90 days (change from start to 2 months and 3 months after start)
measure: pH of biofilm
timeFrame: 90 days (change from start to 2 months and 3 months after start)
measure: extent of gingivitis
timeFrame: 90 days (change from start to 2 months and 3 months after start)
measure: oral health-related quality of life
timeFrame: 90 days (change from start to 2 months and 3 months after start)
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University of Rijeka Faculty of Dental Medicine
city: Rijeka
country: Croatia
facility: University of Rijeka, Faculty od Dental Medicine, Dental Clinic
city: Rijeka
country: Croatia
facility: University of Rijeka, Faculty of Dental Medicine
Study officials:
References: