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NCT03640065 Clinical 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

Gingival Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03640065
Other study ID # CEBD-CU-2018-06-40
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 20, 2019
Est. completion date March 31, 2020

Study information
Verified date December 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 31, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
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

Locations
Country Name City State
Egypt Mai M Ismaiel Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Gingival bleeding On Brushing Patient questioning and answering with yes or no on a questionnaire base line and after 4 weeks
Secondary Change in Dental plaque pH Pooled plaque sample (pH meter) on scale (1-14) base line and after 4 weeks
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