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

December 23, 2020 updated by: Mai Mustafa Samy Ismaiel, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1234
        • Mai M Ismaiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: freeze-dried probiotic sachets
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.
Active Comparator: fermented dairy product (yogurt)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gingival bleeding On Brushing
Time Frame: base line and after 4 weeks
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
Time Frame: base line and after 4 weeks
Pooled plaque sample (pH meter) on scale (1-14)
base line and after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-06-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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