Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

July 13, 2026 updated by: Plovdiv Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv
        • Contact:
        • Principal Investigator:
          • Zalamova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants aged 12 to 17 years.
  2. Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
  3. Generalized plaque-induced gingivitis.
  4. Full Mouth Bleeding Score greater than 30%.
  5. Gingival Index greater than 0.95 according to Loe and Silness.
  6. Written informed consent obtained from a parent or legal guardian.
  7. Participant willingness to comply with the study protocol.

Exclusion Criteria:

  1. Refusal to participate or withdrawal of informed consent.
  2. Non-compliance with the intervention regimen or inability to attend follow-up visits.
  3. Development of an adverse reaction or condition requiring discontinuation.
  4. Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
  5. Presence of concomitant systemic diseases.
  6. Current systemic medication intake that could influence oral health or inflammatory status.
  7. Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
  8. Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
  9. Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Test 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.
Other Names:
  • Sample 1
Active Comparator: 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.
Other: Chlorhexidine-containing 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 Names:
  • Positive control
  • Eludril classic®
Placebo Comparator: 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.
Other: Placebo mouthwash
Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 7, day 21, and 3 months
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.
Baseline, day 7, day 21, and 3 months
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.
Baseline, day 7, day 21, and 3 months
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.
Baseline, day 7, day 21, and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 7, day 21, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plovdiv Medical University

Investigators

  • Principal Investigator: Tanya Zalamova, Plovdiv Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/2024
  • 02/2024 (Other Identifier: Medical University Plovdiv)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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