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Completed

NCT Number: NCT03640065

Evaluation of The Effect of Live Probiotic Cultures Present in Fermented Dairy Product (Yogurt) Versus The Effect of Freeze-Dried Probiotic Sachets on Gingival Bleeding of Adolescents

To evaluate the effect of probiotics supplied in two different forms (dairy products containing probiotics as yogurt and freeze-dried synthetic probiotics sachets) on improving gingival condition and caries potentiality of dental plaque in adolescents

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Key information

Conditions

Gingival Inflammation Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mai M Ismaiel

Cairo, 1234, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 12-15 years old
  • Children complaining from gingival problems
  • Medically free children
  • Children not registered in other clinical researches

Exclusion criteria

  • Children with systemic diseases, mental disorders, chronic debilitating diseases.
  • Children using antibiotic treatment during the study
  • Children with orthodontic treatment
  • Children using antimicrobial mouthwash
  • Children taking any probiotic supplemental therapy

Treatment and study plan

freeze-dried probiotic sachets

Drug
  • The participants will be instructed to consume the sachets as follow, each sachet powder is mixed with 10 ml of water in a measuring cup, then swish the mixture in the mouth for one minute before swallowing.
  • This procedure will be repeated once daily for the following 4 weeks.
  • 4 weeks supply will be given to the participants.

fermented dairy product ( yogurt)

Dietary Supplement
  • The participants will be instructed to consume the yogurt once daily regularly for the following 4 weeks.
  • 4 weeks supply will be given to the participants with instruction to store the yogurt in refrigerator at home

Primary outcomes

  1. Change in Gingival bleeding On Brushing

    Time frame: base line and after 4 weeks

    Patient questioning and answering with yes or no on a questionnaire

Secondary outcomes

  1. Change in Dental plaque pH

    Time frame: base line and after 4 weeks

    Pooled plaque sample (pH meter) on scale (1-14)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Freeze-Dried Probiotic Sachets Versus Fermented Dairy Product (Yogurt) on Gingival Bleeding on Brushing in Adolescents (12-15) Years Old : A Randomized Clinical Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2018
Registry last updated
Dec 24, 2020

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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