Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

NCT07710144 | Not Yet Recruiting

• 2 other identifiers: 17/202402/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plaque-Induced Gingivitis; Dental Plaque Accumulation; Halitosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, day 7, day 21, and 3 months

Secondary Outcomes (1)

• Halitosis Assessment

  Baseline, day 7, day 21, and 3 months

Study Arms (3)

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.

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.

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.

Other: Placebo mouthwash

Interventions

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.

Also known as: Sample 1

Test Mouthwash

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.

Also known as: Eludril classic®, Positive control

Chlorhexidine Mouthwash

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.

Placebo Mouthwash Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

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

Plovdiv, 4000, Bulgaria

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanya Zalamova

  Plovdiv Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya Zalamova

CONTACT

00359878752567; tanya.zalamova@mu-plovdiv.bg

Ani Belcheva, PhD

CONTACT

abeltcheva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)