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Completed

NCT Number: NCT01657539

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

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).

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Key information

Conditions

Dental Caries Oral Health Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Graduate Program in Dentistry, Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: yogurt containing Bifidobacterium animalis

Placebo yogurt

Dietary Supplement

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

Other names: Yogurt without probiotics

Primary outcomes

  1. Cariogenic bacteria reduction

    Time frame: 14 days

    The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient

Secondary outcomes

  1. Patient discomfort with the treatment

    Time frame: 14 days after intervention

    Patients were interviewed regarding any discomfort on the use of the treatments

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Collaborators

  • Pontificia Universidade Católica do Rio Grande do Sul

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 6, 2012
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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