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

NCT ID: NCT05651503

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2025-11-20

Brief 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.

Detailed Description

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 probiotic group C (n=30) and placebo group D (n=30). All participants will consume lozenges for one month. Assessments will be taken at baseline, at the end of the intervention and at a 2 month free-intervention follow-up. The outcome measures will be modified plaque index (PI), modified gingival index (GI) and halitosis-causing volatile sulfur compound (VSC) levels. Results will be announced at the end of the study.

Conditions

Halitosis; Probiotics; Orthodontic Appliance Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental group 1: patients, age 12-18, conventional brackets, Oral probiotics lozenges

30 patients, age 12-18,with conventional brackets,will get Oral probiotics lozenges

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Experimental group 2: patients, age ≥18, Invisalign™ appliances, Oral probiotics lozenges

30 patients, age ≥18, Invisalign™ appliances,wil get Oral probiotics lozenges

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Control group 1: patients, age 12-18, conventional brackets, placebo lozenges

30 patients, age 12-18, conventional brackets,will get placebo lozenges

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

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

Control group 2: patients, age ≥18, Invisalign™ appliances, placebo lozenges

30 patients, age ≥18, Invisalign™ appliances,will get placebo lozenges

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotics

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Align Technology, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Iosif Sifakakis

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iosif Sifakakis, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics

Athens, Attica, Greece

Countries

Greece

Other Identifiers

444/27.07.2020

Identifier Type: -

Identifier Source: org_study_id