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Search / Trial NCT05651503

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

Launched by UNIVERSITY OF ATHENS · Dec 12, 2022

Trial Information

Current as of October 08, 2025

Completed

Keywords

Halitosis Probiotics Fixed Appliances Aligners

ClinConnect Summary

The aim of the study is to investigate the effect of the oral probiotic Lactobacillus salivarius on oral hygiene indices and halitosis in patients wearing orthodontic braces and patients wearing orthodontic aligners. The study is a prospective, randomized, placebo-controlled, double blinded, with four parallel groups and an equal allocation ratio in all groups. Patients 12-18 years old undergoing fixed orthodontic treatment will be randomly allocated to probiotic group A (n=30) and placebo group B (n=30). Patients ≥18 years old wearing aligners (Invisalign™ ) will be randomly allocated to pr...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patients eligible for the trial must comply with all of the following at randomization:
  • Age between 12 and 18 years for the group with conventional orthodontic appliances This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.
  • Age ≥18 for the Invisalign™ group This age group represents the majority of patients seeking orthodontic with aligners (Invisalign™) regarding social status and other factors.
  • Good general health
  • Fixed orthodontic appliances Patients should have fixed labial appliances (brackets) on all teeth from central incisor to first molar, in both the maxillary and the mandibular arch. Fixed appliances should have been placed at least two months before the patient is accepted into the study and remaining treatment should be at least 3 months. All brackets will be the same (metallic, conventional/not self-ligating, same size). Molars should be banded (same bands on all molars) and all other teeth bonded.
  • At least 20 natural teeth (in case of extraction orthodontic treatment patients can be enrolled two months after extractions) The outcomes will be evaluated at all teeth from first molar to first molar.
  • Exclusion Criteria:
  • * Patients will be excluded for any of the following reasons:
  • Active caries
  • Periodontitis
  • Syndromes, mental disabilities and craniofacial deformities
  • Smoking or use of other tobacco products
  • Dental fluorosis/tooth malformation
  • Antibiotics during the last 2 months
  • chlorhexidine in the previous 3 week
  • Suffering from any disease within 2 months before measurements
  • Allergy to dairy products
  • Participation in other trials Consent / assent Parents/guardians and patients will provide written informed consent and patients will provide written assent before randomization and before any procedures are applied.

About University Of Athens

The University of Athens, a leading institution in medical research and education, is dedicated to advancing healthcare through innovative clinical trials. With a robust infrastructure and a multidisciplinary team of experts, the university focuses on translating scientific discoveries into practical applications that benefit patient care. Its commitment to ethical standards and rigorous methodologies ensures that all trials conducted under its auspices adhere to the highest principles of research integrity. By fostering collaboration with national and international partners, the University of Athens aims to contribute significantly to the global medical community and improve health outcomes through evidence-based practices.

Locations

Athens, Attiki, Greece

Patients applied

0 patients applied

Trial Officials

Iosif Sifakakis, Associate Professor

Principal Investigator

University of Athens

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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