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NCT Number: NCT07710144

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.

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Key information

Conditions

Plaque-Induced Gingivitis Dental Plaque Accumulation Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv

Plovdiv, 4000, Bulgaria

Location contact

Tanya Zalamova

CONTACT

[email protected]

00359878752567

Zalamova

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test mouthwash

Other

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 names: Sample 1

Chlorhexidine-containing mouthwash

Other

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 names: Eludril classic®, Positive control

Placebo Mouthwash

Other

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 outcomes

  1. Orthodontic Plaque Index (OPI)

    Time frame: Baseline, day 7, day 21, and 3 months

    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.

  2. Gingival Index (Loe & Silness)

    Time frame: Baseline, day 7, day 21, and 3 months

    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.

  3. Full Mouth Bleeding Score (FMBS)

    Time frame: Baseline, day 7, day 21, and 3 months

    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.

  4. Full Mouth Plaque Score (FMPS)

    Time frame: Baseline, day 7, day 21, and 3 months

    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.

Secondary outcomes

  1. Halitosis Assessment

    Time frame: Baseline, day 7, day 21, and 3 months

    Halitosis was assessed by gas chromatography using OralChroma™. Volatile sulfur compounds were measured, including hydrogen sulfide, methyl mercaptan and dimethyl sulfide.

Study contacts

Contact information is provided by the study sponsor or research team.

Ani Belcheva, PhD

CONTACT

[email protected]

Tanya Zalamova

CONTACT

[email protected]

00359878752567

Sponsors and collaborators

Lead sponsor

Plovdiv Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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