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

NCT01657539 | Completed Phase 2

• 1 other identifier: UFPEL-PPGO0013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Caries; Oral Health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient discomfort with the treatment

  14 days after intervention

Study Arms (2)

Probiotics

EXPERIMENTAL

Group of patients using yogurt containing probiotics during the experimental phase of the study.

Dietary Supplement: Yogurt containing probiotics

Control Yogurt

PLACEBO COMPARATOR

Group of patients that will use a placebo yogurt for providing comparison with the experimental group.

Dietary Supplement: Placebo yogurt

Interventions

Yogurt containing probiotics DIETARY_SUPPLEMENT

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

Also known as: yogurt containing Bifidobacterium animalis

Probiotics

Placebo yogurt DIETARY_SUPPLEMENT

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

Also known as: Yogurt without probiotics

Control Yogurt

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• excellent oral health
• patients under bimaxillary orthodontic treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead
• Pontificia Universidade Católica do Rio Grande do Sul: collaborator

Study Sites (1)

Graduate Program in Dentistry, Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Yogurt; Probiotics

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages; Dietary Supplements

Study Officials

• Maximiliano S Cenci, PhD

  Graduate Program in Dentistry, Federal University of Pelotas

  STUDY CHAIR

• Gabriela S Pinto, MSc

  Graduate Program in Dentistry, Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Clinical Trial, Graduate of Program of Dentistry

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

BR (1)