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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 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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03640065
Enrollment
20
Registered
2018-08-21
Start date
2019-10-20
Completion date
2020-03-31
Last updated
2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Inflammation

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

Interventions

DRUGfreeze-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_SUPPLEMENTfermented 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

only statistician was blind known participants only by codes

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Gingival bleeding On Brushingbase line and after 4 weeksPatient questioning and answering with yes or no on a questionnaire

Secondary

MeasureTime frameDescription
Change in Dental plaque pHbase line and after 4 weeksPooled plaque sample (pH meter) on scale (1-14)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026