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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640065
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mai Mustafa Samy Ismaiel, Cairo University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Gingival Inflammation Drug: freeze-dried probiotic sachets Dietary Supplement: fermented dairy product ( yogurt) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 20, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: freeze-dried probiotic sachets Drug: freeze-dried probiotic sachets
  • 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.

Active Comparator: fermented dairy product (yogurt) Dietary Supplement: fermented dairy product ( yogurt)
  • 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 Outcome Measures :
  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 Outcome Measures :
  1. Change in Dental plaque pH [ Time Frame: base line and after 4 weeks ]
    Pooled plaque sample (pH meter) on scale (1-14)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children aged 12-15 years old
  2. Children complaining from gingival problems
  3. Medically free children
  4. Children not registered in other clinical researches

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640065


Contacts
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Contact: Mai M Ismaiel, Master 020106330775 momo_dentist88@yahoo.com

Locations
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Egypt
Mai M Ismaiel Recruiting
Cairo, Egypt, 1234
Contact: Mai M Ismaiel    020106330775 ext 020106330775    momo_dentist88@yahoo.com   
Sponsors and Collaborators
Cairo University
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Responsible Party: Mai Mustafa Samy Ismaiel, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03640065    
Other Study ID Numbers: CEBD-CU-2018-06-40
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingivitis
Gingival Hemorrhage
Inflammation
Pathologic Processes
Hemorrhage
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Oral Hemorrhage