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Not yet recruiting NCT07710144

Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

No phase Interventional Plaque-Induced Gingivitis Dental Plaque Accumulation Halitosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test mouthwash, Chlorhexidine-containing mouthwash, Placebo mouthwash.
Who it may be relevant to
Registry conditions: Plaque-Induced Gingivitis, Dental Plaque Accumulation, Halitosis. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

Overview

Fixed metal orthodontic appliances create additional plaque-retentive areas around brackets, archwires and ligatures, making mechanical plaque control more difficult in children and adolescents. Increased plaque accumulation may contribute to gingival inflammation, bleeding, halitosis and early enamel changes. Therefore, adjunctive preventive agents, including mouthwashes, may be clinically useful as part of a comprehensive oral hygiene program during fixed orthodontic treatment. The aim of the study is to evaluate the clinical effectiveness and tolerability of a test mouthwash in children and adolescents with fixed orthodontic appliances by monitoring plaque accumulation, gingival inflammation, gingival bleeding and halitosis.

Interventions

  • Other Test mouthwash
    Participants rinsed with a 15 ml prototype chlorhexidine-free pediatric mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
  • Other Chlorhexidine-containing mouthwash
    Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
  • Other Placebo mouthwash
    Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.

Primary outcome measures

  • Orthodontic Plaque Index (OPI) [Time frame: Baseline, day 7, day 21, and 3 months]
  • Gingival Index (Loe & Silness) [Time frame: Baseline, day 7, day 21, and 3 months]
  • Full Mouth Bleeding Score (FMBS) [Time frame: Baseline, day 7, day 21, and 3 months]
  • Full Mouth Plaque Score (FMPS) [Time frame: Baseline, day 7, day 21, and 3 months]
Secondary outcome measures (1)
  • Halitosis Assessment [Time frame: Baseline, day 7, day 21, and 3 months]

Eligibility criteria

Inclusion criteria

  • Participants aged 12 to 17 years.
  • Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
  • Generalized plaque-induced gingivitis.
  • Full Mouth Bleeding Score greater than 30%.
  • Gingival Index greater than 0.95 according to Loe and Silness.
  • Written informed consent obtained from a parent or legal guardian.
  • Participant willingness to comply with the study protocol.

Exclusion criteria

  • Refusal to participate or withdrawal of informed consent.
  • Non-compliance with the intervention regimen or inability to attend follow-up visits.
  • Development of an adverse reaction or condition requiring discontinuation.
  • Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
  • Presence of concomitant systemic diseases.
  • Current systemic medication intake that could influence oral health or inflammatory status.
  • Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
  • Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
  • Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Bulgaria · 1 center
  • Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plov — Plovdiv

Identifiers

NCT: NCT07710144 · 17/2024 · 02/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗