Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorPlovdiv Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Test mouthwash
Other interventionParticipants 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.
Chlorhexidine-containing mouthwash
Other interventionParticipants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
Placebo mouthwash
Other interventionParticipants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Test MouthwashExperimental treatment 1 intervention
Group B: Chlorhexidine MouthwashActive comparator 1 intervention
Group C: Placebo Mouthwash GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Orthodontic Plaque Index (OPI)
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.
Time frame
Baseline, day 7, day 21, and 3 months2
Gingival Index (Loe & Silness)
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.
Time frame
Baseline, day 7, day 21, and 3 months3
Full Mouth Bleeding Score (FMBS)
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.
Time frame
Baseline, day 7, day 21, and 3 months4
Full Mouth Plaque Score (FMPS)
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.
Time frame
Baseline, day 7, day 21, and 3 monthsSecondary outcomes
1
Halitosis Assessment
Halitosis was assessed by gas chromatography using OralChroma™. Volatile sulfur compounds were measured, including hydrogen sulfide, methyl mercaptan and dimethyl sulfide.
Time frame
Baseline, day 7, day 21, and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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