Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment

Effects of Yogurt Containing Bifidobacterium Animalis Ssp. Lactis dn- 1173010 Probiotics in the Composition of Biofilms and Saliva of Orthodontic Patients: a Crossover, Double-blind, Randomized and Placebo Controlled Clinical Trial.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01657539

Enrollment

Registered

2012-08-06

Start date

2011-08-31

Completion date

2013-03-31

Last updated

2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Oral Health

Brief summary

Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. Experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values before and after the treatment will be compared with Wilcoxon's test (p\<0.05).

Interventions

DIETARY_SUPPLEMENTYogurt containing probiotics

patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.

DIETARY_SUPPLEMENTPlacebo yogurt

Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

* excellent oral health * patients under bimaxillary orthodontic treatment

Exclusion criteria

* any chronic disease * antibiotics and/or antimicrobial use in the previous 3 weeks * topic fluoride or chlorhexidine use in the previous 3 weeks * presence of cavitated or active carious lesions * patients with intolerance to lactose.

Design outcomes

Primary

Measure	Time frame	Description
Cariogenic bacteria reduction	14 days	The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient

Secondary

Measure	Time frame	Description
Patient discomfort with the treatment	14 days after intervention	Patients were interviewed regarding any discomfort on the use of the treatments

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026