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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03640065

Collaborator

(none)

Enrollment

Location

Arms

5.4

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gingival Inflammation	Drug: freeze-dried probiotic sachets Dietary Supplement: fermented dairy product ( yogurt)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

only statistician was blind known participants only by codes

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 20, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Gingival bleeding On Brushing [base line and after 4 weeks]
Patient questioning and answering with yes or no on a questionnaire

Secondary Outcome Measures

Change in Dental plaque pH [base line and after 4 weeks]
Pooled plaque sample (pH meter) on scale (1-14)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mai M Ismaiel	Cairo		Egypt	1234

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mai Mustafa Samy Ismaiel, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT03640065

Other Study ID Numbers:

CEBD-CU-2018-06-40

First Posted:

Aug 21, 2018

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Gingival Hemorrhage

Inflammation

Study Results

No Results Posted as of Dec 24, 2020