Back to resultsThe Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.
Primary Purpose
Halitosis, Probiotics, Orthodontic Appliance Complication
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Prodilac Oral, Frezyderm
placebo lozenges
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis focused on measuring Halitosis, Probiotics, Fixed Appliances, Aligners
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.
Sites / Locations
- National and Kapodistrian University of Athens, School of Dentistry, Departments of OrthodonticsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
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
Arm Description
30 patients, age 12-18,with conventional brackets,will get Oral probiotics lozenges
30 patients, age ≥18, Invisalign™ appliances,wil get Oral probiotics lozenges
30 patients, age 12-18, conventional brackets,will get placebo lozenges
30 patients, age ≥18, Invisalign™ appliances,will get placebo lozenges
Outcomes
Primary Outcome Measures
Modified Silness and Löe plaque index (PI-M)
The Silness and Löe index does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Modified Silness and Löe plaque index (PI-M)
The Silness and Löe index does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Modified Gingival index (GI-M)
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding .
Modified Gingival index (GI-M)
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding.
Halitosis/ VSCs levels
VSCs levels will recorded at each time point with the use of OralChromaTM. OralChromaTM is a portable gas chromatograph, which uses ambient air as a carrier gas and a semiconductor (In2O3) gas sensor to detect volatile sulphur compounds (VSCs), i.e. the concentrations of H2S, CH3SH and (CH3)2S.
Halitosis/ VSCs levels
VSCs levels will recorded at each time point with the use of OralChromaTM. OralChromaTM is a portable gas chromatograph, which uses ambient air as a carrier gas and a semiconductor (In2O3) gas sensor to detect volatile sulphur compounds (VSCs), i.e. the concentrations of H2S, CH3SH and (CH3)2S.
Secondary Outcome Measures
Full Information
NCT ID
NCT05651503
First Posted
December 2, 2022
Last Updated
December 12, 2022
Sponsor
University of Athens
Collaborators
Align Technology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05651503
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
Collaborators
Align Technology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis, Probiotics, Orthodontic Appliance Complication
Keywords
Halitosis, Probiotics, Fixed Appliances, Aligners
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
Masking Description
Two random sequences will be obtained for each age group from www.random.org (2 for patients 12-18 yo and 2 for patients ≥18 yo), one for males and one for females in each age group. Each sequence will be a random ordering of a list of 30 'Ex's and 30 'Co's (Ex: Probiotic, Co: Placebo). The sequence values will be written on standard-sized pieces of paper using a pencil and sealed in opaque numbered envelopes (sequentially numbered from F1 to F30 (female group) and M1 to M30 (male group)) for each group by a person not involved in the project.
The different lozenges will be labeled 1 or 2 by the manufacturer. The packaging, appearance and taste of lozenges in both intervention and control groups will be identical.
Clinical measurements of plaque accumulation, gingival inflammation and VSCs levels will be conducted by an assessor blind to treatment allocation. Due to the nature of the intervention, participants and patients can be blinded to allocation.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group 1: patients, age 12-18, conventional brackets, Oral probiotics lozenges
Arm Type
Experimental
Arm Description
30 patients, age 12-18,with conventional brackets,will get Oral probiotics lozenges
Arm Title
Experimental group 2: patients, age ≥18, Invisalign™ appliances, Oral probiotics lozenges
Arm Type
Experimental
Arm Description
30 patients, age ≥18, Invisalign™ appliances,wil get Oral probiotics lozenges
Arm Title
Control group 1: patients, age 12-18, conventional brackets, placebo lozenges
Arm Type
Placebo Comparator
Arm Description
30 patients, age 12-18, conventional brackets,will get placebo lozenges
Arm Title
Control group 2: patients, age ≥18, Invisalign™ appliances, placebo lozenges
Arm Type
Placebo Comparator
Arm Description
30 patients, age ≥18, Invisalign™ appliances,will get placebo lozenges
Intervention Type
Dietary Supplement
Intervention Name(s)
Prodilac Oral, Frezyderm
Intervention Description
In our study oral probiotics Lactobacillus salivarius Oral S1 11 (Prodilac Oral, Frezyderm) will be tested in two Experimental groups
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo lozenges
Intervention Description
In order to avoid possible bias, probiotics will be compared with placebo lozenges/no probiotic in two Control groups
Primary Outcome Measure Information:
Title
Modified Silness and Löe plaque index (PI-M)
Description
The Silness and Löe index does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Time Frame
baseline-1 month
Title
Modified Silness and Löe plaque index (PI-M)
Description
The Silness and Löe index does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Time Frame
1 month- 3 month
Title
Modified Gingival index (GI-M)
Description
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding .
Time Frame
baseline-1 month
Title
Modified Gingival index (GI-M)
Description
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding.
Time Frame
1 month- 3 month
Title
Halitosis/ VSCs levels
Description
VSCs levels will recorded at each time point with the use of OralChromaTM. OralChromaTM is a portable gas chromatograph, which uses ambient air as a carrier gas and a semiconductor (In2O3) gas sensor to detect volatile sulphur compounds (VSCs), i.e. the concentrations of H2S, CH3SH and (CH3)2S.
Time Frame
baseline-1 month
Title
Halitosis/ VSCs levels
Description
VSCs levels will recorded at each time point with the use of OralChromaTM. OralChromaTM is a portable gas chromatograph, which uses ambient air as a carrier gas and a semiconductor (In2O3) gas sensor to detect volatile sulphur compounds (VSCs), i.e. the concentrations of H2S, CH3SH and (CH3)2S.
Time Frame
1 month- 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iosif Sifakakis, Assistant Professor
Phone
00306944654456
Email
isifak@dent.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Iosif Sifakakis, Assistant Professor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iosif Sifakakis, Assistant Professor
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iosif Sifakakis, Assistant proffesor
Phone
00302107461228
Email
isifak@dent.uoa.gr
12. IPD Sharing Statement
Learn more about this trial
The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.
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