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

NCT03640065 | Completed Phase 4

• 1 other identifier: CEBD-CU-2018-06-40
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Gingival bleeding On Brushing

  Patient questioning and answering with yes or no on a questionnaire

  base line and after 4 weeks

Secondary Outcomes (1)

• Change in Dental plaque pH

  base line and after 4 weeks

Study Arms (2)

freeze-dried probiotic sachets

EXPERIMENTAL

Drug: freeze-dried probiotic sachets

fermented dairy product (yogurt)

ACTIVE COMPARATOR

Dietary Supplement: fermented dairy product ( yogurt)

Interventions

freeze-dried probiotic sachets DRUG

* 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.

freeze-dried probiotic sachets

fermented dairy product ( yogurt) DIETARY_SUPPLEMENT

* 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

fermented dairy product (yogurt)

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 12-15 years old
• Children complaining from gingival problems
• Medically free children
• Children not registered in other clinical researches

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mai M Ismaiel

Cairo, 1234, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Cultured Milk Products; Yogurt

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: only statistician was blind known participants only by codes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: October 20, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 31, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

EG (1)