An interventional study of Test mouthwash and Chlorhexidine-containing mouthwash in Plaque-Induced Gingivitis, Dental Plaque Accumulation and Halitosis, sponsored by Plovdiv Medical University. Not yet recruiting at 1 site in Bulgaria. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Plovdiv Medical University · Not applicable, Interventional, and Prevention
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's planned enrollment of 90 is above the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Plovdiv Medical University is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Test 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: Chlorhexidine-containing mouthwash
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.
Other: Placebo 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.
Also known as: Sample 1
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.
Also known as: Eludril classic®, Positive control
Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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 months
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 months
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 months
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 months
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 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 35 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's planned 3 months is below that.
Counting every sponsor, half of 43 studies reached it within 10 months; a quarter within 3 and three quarters within 18.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Plovdiv Medical University