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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gingival Inflammation

Intervention / Treatment
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* Drug: freeze-dried probiotic sachets
* Dietary Supplement: fermented dairy product ( yogurt)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: freeze-dried probiotic sachets<br> | Drug: freeze-dried probiotic sachets<br>* 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.<br>|
| Active Comparator: fermented dairy product (yogurt)<br> | Dietary Supplement: fermented dairy product ( yogurt)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gingival bleeding On Brushing | Patient questioning and answering with yes or no on a questionnaire | base line and after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dental plaque pH | Pooled plaque sample (pH meter) on scale (1-14) | base line and after 4 weeks |