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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Gingival Hemorrhage
• Gingival Inflammation
• Gingivitis
• Inflammation

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