Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tanya Zalamova
- Telefonnummer: 00359878752567
- E-post: Tanya.Zalamova@mu-plovdiv.bg
Studer Kontakt Backup
- Navn: Ani Belcheva, PhD
- E-post: abeltcheva@gmail.com
Studiesteder
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Plovdiv, Bulgaria, 4000
- Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv
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Ta kontakt med:
- Tanya Zalamova
- Telefonnummer: 00359878752567
- E-post: Tanya.Zalamova@mu-plovdiv.bg
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Hovedetterforsker:
- Zalamova
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Test Mouthwash
Participants rinsed with 15 ml of the prototype chlorhexidine-free pediatric mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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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.
Andre navn:
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Aktiv komparator: Chlorhexidine 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.
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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.
Andre navn:
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Placebo komparator: Placebo Mouthwash Group
Participants rinsed with 15 ml of the placebo mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Orthodontic Plaque Index (OPI)
Tidsramme: Baseline, day 7, day 21, and 3 months
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The Orthodontic Plaque Index focuses on the areas around the bracket, which represents an additional plaque-retentive factor. The dentition is divided into sextants and plaque accumulation is scored from 0 to 4. The mesial, distal, incisal and cervical areas around each bracket are evaluated. The highest score among all sextants defines the oral hygiene level and identifies the need for preventive measures. Registry field data Code 0 No plaque accumulation is detected. Code 1 Plaque accumulation is detected on one tooth surface around the bracket base. Code 2 Plaque accumulation is detected on two tooth surfaces around the bracket base. Code 3 Plaque accumulation is detected on three tooth surfaces around the bracket base; increased risk of caries and gingivitis is assumed. Code 4 Plaque accumulation is detected on all tooth surfaces around the bracket base and/or gingival inflammation is present. |
Baseline, day 7, day 21, and 3 months
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Gingival Index (Loe & Silness)
Tidsramme: Baseline, day 7, day 21, and 3 months
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The index evaluates color, contour and bleeding of the gingival tissues. A World Health Organization (WHO) 621 periodontal probe is used to examine the gingival sulcus, and bleeding is recorded within 10 seconds. Code 0 Normal gingiva. Code 1 Mild inflammation: slight color change and slight edema, without bleeding on probing. Code 2 Moderate inflammation: redness, edema and glazing, with bleeding on probing. Code 3 Severe inflammation: marked redness and edema, ulceration and tendency to spontaneous bleeding. |
Baseline, day 7, day 21, and 3 months
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Full Mouth Bleeding Score (FMBS)
Tidsramme: Baseline, day 7, day 21, and 3 months
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FMBS assesses provoked bleeding from the gingival sulcus using a WHO 621 periodontal probe.
Bleeding is recorded within 10 seconds and marked as present (+) or absent (-).
The index is calculated as the percentage of gingival sites with provoked bleeding from all examined sites for each child.
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Baseline, day 7, day 21, and 3 months
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Full Mouth Plaque Score (FMPS)
Tidsramme: Baseline, day 7, day 21, and 3 months
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Dental plaque accumulation was assessed using the Full Mouth Plaque Score.
The presence of visible plaque was recorded on tooth surfaces, and the result was expressed as the percentage of plaque-positive sites.
Lower percentages indicate improved plaque control.
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Baseline, day 7, day 21, and 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Halitosis Assessment
Tidsramme: Baseline, day 7, day 21, and 3 months
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Halitosis was assessed by gas chromatography using OralChroma™.
Volatile sulfur compounds were measured, including hydrogen sulfide, methyl mercaptan and dimethyl sulfide.
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Baseline, day 7, day 21, and 3 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tanya Zalamova, Plovdiv Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17/2024
- 02/2024 (Annen identifikator: Medical University Plovdiv)
Plan for individuelle deltakerdata (IPD)
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