Dental Hygiene, Gingivitis and Periodontal Diseases, Orthodontics
Conditions
Keywords
probiotics, Fixed orthodontic, oral hygiene, clear aligners
Brief summary
Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.
Interventions
DIETARY_SUPPLEMENTUse of probiotics during oral hygiene at home
The probiotic used in the study is Bifidobacterium Lactis HN019, distributed com-mercially in Italy by Curasept (Curasept Prevent®, Curasept S.p.A., Saronno, VA, Italy), with added Kluyveromyces Marxianus Fragilis B0399, colostrum and biotin. The probiotic was taken by patients following the manufacturer's directions via 2 chewable tablets daily, morning and evening, after normal daily oral hygiene, achieving daily average values of B. Lactis HN019 of 2\*107 CFU and Kluyveromyces marxianus fragilis B0399 of 2\*109 CFU.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The operator performing the data collection was unaware of the group membership of the evaluated patient
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* age range of 10 to 30 years old; * good general health; * patients undergoing fixed multibracket orthodontic treatment; * patients undergoing invisible aligner orthodontic treatment.
Exclusion criteria
* physical, mental or motor disabilities; * systemic conditions that influence the progression of gingivitis; * presence of non-plaque-induced gingivitis; * known allergies; * smokers (if more than 5 cigarettes per day); * use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full Mouth Bleeding Score (FMBS) | 4 months | FMBS is a dichotomous index indicating the presence of gingival bleeding on 6 surfaces, the same as FMPS, after light probing. The ratio of surfaces with bleeding to the total of the assessed surfaces is presented as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full Mouth Plaque Score (FMPS) | 4 months | FMPS is a dichotomous index indicating the presence of bacterial biofilm on 6 tooth surfaces: mesio-vestibular, vestibular, disto-vestibular, disto-palatal/lingual, pala-tal/lingual, and mesio-palatal/lingual. The ratio of surfaces with plaque to the total of the assessed surfaces is presented as a percentage. |
Countries
Italy
Outcome results
None listed