Gingival InflammationPhase 4NCT03640065
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
A Phase 4 study testing freeze-dried probiotic sachets and fermented dairy product ( yogurt) in people with Gingival Inflammation, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- freeze-dried probiotic sachets and fermented dairy product ( yogurt)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 31 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 12-15 years old
- Children complaining from gingival problems
- Medically free children
- Children not registered in other clinical researches
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- freeze-dried probiotic sachets, fermented dairy product ( yogurt)
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
freeze-dried probiotic sachetsDrug
- 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.
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
| Study group | Role | What they receive |
|---|---|---|
| freeze-dried probiotic sachets | Experimental | Not described Receives: Drug: freeze-dried probiotic sachets |
| fermented dairy product (yogurt) | Active comparator | Not described Receives: Dietary Supplement: fermented dairy product ( yogurt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival bleeding On Brushing
Patient questioning and answering with yes or no on a questionnaire
Measured: base line and after 4 weeks
Secondary outcomes (1)
Change in Dental plaque pH
Pooled plaque sample (pH meter) on scale (1-14)
Measured: base line and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start20 Oct 2019
- Primary completion1 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mustafa Samy Ismaiel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640065
- Sponsor's protocol ID
- CEBD-CU-2018-06-40
- Status last verified
- Dec 2020
- First submitted
- 15 Aug 2018
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03640065
- Acronym / sponsor ID
- CEBD-CU-2018-06-40
- Conditions
- Gingival Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freeze-dried probiotic sachets | Experimental | Drug: freeze-dried probiotic sachets |
| fermented dairy product (yogurt) | Active comparator | Dietary Supplement: fermented dairy product ( yogurt) |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 12-15 years old
- Children complaining from gingival problems
- Medically free children
- Children not registered in other clinical researches
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | freeze-dried probiotic sachets |
| 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 | Dietary supplement | fermented dairy product (yogurt) |
Primary outcome
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
1 secondary outcome
Change in Dental plaque pH
Time frame: base line and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing freeze-dried probiotic sachets and fermented dairy product ( yogurt) in people with Gingival Inflammation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival bleeding On Brushing (time frame: base line and after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.