Back to resultsEvaluation 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
Primary Purpose
Gingival Inflammation
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
freeze-dried probiotic sachets
fermented dairy product ( yogurt)
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Inflammation
Eligibility Criteria
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
Sites / Locations
- Mai M Ismaiel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
freeze-dried probiotic sachets
fermented dairy product (yogurt)
Arm Description
Outcomes
Primary Outcome Measures
Change in Gingival bleeding On Brushing
Patient questioning and answering with yes or no on a questionnaire
Secondary Outcome Measures
Change in Dental plaque pH
Pooled plaque sample (pH meter) on scale (1-14)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640065
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
only statistician was blind known participants only by codes
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
freeze-dried probiotic sachets
Arm Type
Experimental
Arm Title
fermented dairy product (yogurt)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
freeze-dried probiotic sachets
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
fermented dairy product ( yogurt)
Intervention Description
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 Measure Information:
Title
Change in Gingival bleeding On Brushing
Description
Patient questioning and answering with yes or no on a questionnaire
Time Frame
base line and after 4 weeks
Secondary Outcome Measure Information:
Title
Change in Dental plaque pH
Description
Pooled plaque sample (pH meter) on scale (1-14)
Time Frame
base line and after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mai M Ismaiel
City
Cairo
ZIP/Postal Code
1234
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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