Clinical trial NCT05651503: The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.
Official title: The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Probiotics
Orthodontic Appliance Complication
Keywords: Halitosis
Probiotics
Fixed Appliances
Aligners
Lead sponsor: University of Athens
Sponsor class: OTHER
Collaborators: name: Align Technology, Inc.
First posted: 2022-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded, with four parallel groups and an equal allocation ratio in all groups. In this dose study, the intervention consists of delivery of oral probiotics Lactobacillus Salivarius or placebo lozenges.

Equal number of males and females will be allocated to each group. In our study oral probiotics Lactobacillus salivarius Oral S1 11 (Prodilac Oral, Frezyderm) will be tested in two different groups:

Experimental group 1: patients, age 12-18, conventional brackets, Oral probiotics lozenges Experimental group 2: patients, age ≥18, Invisalign™ appliances, Oral probiotics lozenges Control group 1: patients, age 12-18, conventional brackets, placebo lozenges Control group 2: patients, age ≥18, Invisalign™ appliances, placebo lozenges
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Modified Silness and Löe plaque index (PI-M)
timeFrame: baseline-1 month
measure: Modified Silness and Löe plaque index (PI-M)
timeFrame: 1 month- 3 month
measure: Modified Gingival index (GI-M)
timeFrame: baseline-1 month
measure: Modified Gingival index (GI-M)
timeFrame: 1 month- 3 month
measure: Halitosis/ VSCs levels
timeFrame: baseline-1 month
measure: Halitosis/ VSCs levels
timeFrame: 1 month- 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
state: Attiki
Study officials:
affiliation: University of Athens
name: Iosif Sifakakis, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: