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The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.

NCT05651503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-10

No results posted yet for this study

Summary

Brackets, bands, ligatures and wires in patients receiving orthodontic treatment with fixed appliances are areas that trap food and impede oral hygiene. An ecological environment facilitating the growth of microorganisms (Actinobacillus, Bacteroides, Prevotella etc.) emerges in the mouth and may cause caries, enamel white spots, gingival inflammation and halitosis. Despite the use of specialized orthodontic brushes, interdental brushes, mouthwashes and topical fluorides, plaque removal remains inadequate in patients with fixed orthodontic appliances. On the other hand, patients undergoing orthodontic treatment with aligners have been found to have better oral hygiene because of less plaque accumulation in their mouth.

Probiotics are defined as non-pathogenic bacteria that can benefit the host's general health when taken in sufficient amounts through nutrition. Nowadays probiotics can be used to enhance oral health as they are found to reduce dental biofilm formation, prevent and decrease halitosis in children, adolescents and adults. To date, there are few randomized controlled trials (RCTs) examining the efficacy of oral probiotics in patients with fixed orthodontic appliances and none reporting the incidence of halitosis and the effect of probiotics in orthodontic patients wearing aligners.

Conditions

  • Halitosis
  • Probiotics
  • Orthodontic Appliance Complication

Interventions

DIETARY_SUPPLEMENT

Probiotics

In our study oral probiotics Lactobacillus salivarius Oral S1 11 (Prodilac Oral, Frezyderm) will be tested in two Experimental groups

DIETARY_SUPPLEMENT

Placebo tablet

In order to avoid possible bias, probiotics will be compared with placebo lozenges/no probiotic in two Control groups

Sponsors & Collaborators

  • Align Technology, Inc.

    collaborator INDUSTRY

  • University of Athens

    lead OTHER

Principal Investigators

  • Iosif Sifakakis, Associate Professor · University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2025-11-20
Completion
2025-11-20

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651503 on ClinicalTrials.gov