Currently submitted to: JMIR Research Protocols
Date Submitted: Feb 26, 2026
Open Peer Review Period: Mar 3, 2026 - Apr 28, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Impact of a personalized preventive approach on oral microbial homeostasis during fixed orthodontic treatment: Protocol for a randomized Controlled study
ABSTRACT
Background:
Fixed orthodontic appliances create new retentive niches that favour dental biofilm accumulation and are associated with enamel demineralization and periodontal inflammation. Beyond these clinical effects, orthodontic treatment may induce shifts in the oral microbial ecosystem (commonly referred to as dysbiosis), potentially influenced by individual host–microbiota interactions.
Objective:
This study aims to evaluate whether an intensive personalized prevention strategy, added to standard orthodontic care, limits orthodontic treatment–associated microbial dysbiosis, defined as longitudinal quantitative shifts from commensal toward pathogenic microbial complexes, during the first year of fixed orthodontic treatment, compared with standard care alone.
Methods:
This is a prospective, multicenter, randomized, open-label, parallel-arm interventional study with a 12-month follow-up. Eighty participants aged 12–20 years requiring fixed orthodontic treatment will be randomized in 1:1 ratio to receive either (i) standard care or (ii) standard care plus personalized prevention. The preventive intervention includes repeated oral health education sessions, supervised toothbrushing, dietary education, plaque disclosure, and chairside prophylaxis using a standardized professional protocol. Study visits are scheduled at appliance placement (baseline) and at 3, 6, 9, and 12 months (±10 days). The primary endpoint is the longitudinal change in quantities of selected bacterial and viral species in saliva and dental biofilm assessed using high-throughput microfluidic qPCR. Secondary endpoints include salivary inflammatory profiling (cytokines/chemokines), clinical indices (plaque index, bleeding on probing, white spot lesions), compliance measures (wear of oral hygiene devices and toothpaste consumption by weight), and participant satisfaction. Analysis will follow a modified intention-to-treat approach, complemented by per-protocol analyses.
Results:
The study will include a 6-month enrolment period with baseline data collection, followed by 12 months of participant follow-up. The total study duration is expected to be 24 months. Data analysis and reporting are planned upon completion of follow-up.
Conclusions:
PREPERMIO is a randomized interventional study evaluating a personalized preventive strategy during fixed orthodontic treatment using biologically driven longitudinal endpoints. By focusing on microbial homeostasis and bacterial community shifts, and integrating bacterial, viral, and host inflammatory markers, it addresses limitations of prior studies centered mainly on clinical or behavioural outcomes and has the potential to inform future personalized prevention strategies in orthodontics. Clinical Trial: NCT06752902
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