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

Dental Caries Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657539
• Other study ID #: UFPEL-PPGO0013
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 2, 2012
• Last updated: September 17, 2013
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries
• Oral Health

Intervention

Dietary Supplement:
• Yogurt 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.
• Placebo yogurt
Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes

Locations

Country	Name	City	State
Brazil	Graduate Program in Dentistry, Federal University of Pelotas	Pelotas	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Pelotas	Pontificia Universidade Católica do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cariogenic bacteria reduction	The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient	14 days	No
Secondary	Patient discomfort with the treatment	Patients were interviewed regarding any discomfort on the use of the treatments	14 days after intervention	Yes