Plaque-Induced GingivitisNCT07710144
Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
A study testing Test mouthwash and Chlorhexidine-containing mouthwash in people with Plaque-Induced Gingivitis and Dental Plaque Accumulation, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Plaque-Induced Gingivitis, Dental Plaque Accumulation, Halitosis
- What is being tested?
- Test mouthwash and Chlorhexidine-containing mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2026to 31 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ani Belcheva, PhD contact
Bulgaria1 site
Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv
Plovdiv, 4000
Tanya Zalamova, 00359878752567, Tanya.Zalamova@mu-plovdiv.bg
Zalamova
About this study
Official title: 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.
- Being tested
- Test mouthwash, Chlorhexidine-containing mouthwash, Placebo mouthwash
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mouthwashOther
Also called Sample 1
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.
Chlorhexidine-containing mouthwashOther
Also called Eludril classic®, Positive control
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.
Placebo mouthwashOther
Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Test Mouthwash | Experimental | 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. Receives: Other: Test mouthwash |
| Chlorhexidine Mouthwash | Active comparator | 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. Receives: Other: Chlorhexidine-containing mouthwash |
| Placebo Mouthwash Group | Placebo comparator | 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. Receives: Other: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, day 7, day 21, and 3 months
Secondary 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.
Measured: Baseline, day 7, day 21, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, parallel-group interventional study with three arms. Participants were assigned to receive either a prototype chlorhexidine-free pediatric mouthwash, a chlorhexidine-containing mouthwash, or a placebo mouthwash for 21 days as an adjunct to standard oral hygiene.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya Zalamova, Principal investigator, Plovdiv Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710144
- Sponsor's protocol ID
- 17/2024
- Other IDs
- 02/2024
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No