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NOT YET RECRUITING
NCT07710144
NA

Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

Sponsor: Plovdiv Medical University

View on ClinicalTrials.gov

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.

Official title: Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-09-01

Completion Date

2028-05-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

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

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

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.

Locations (1)

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

Plovdiv, Bulgaria