Geriatric PatientsNCT03889015
Antibacterial Effect of Probiotic Yogurt Compared to Xylitol
A study testing Probiotic yogurt and xylitol chewing gum in people with Geriatric Patients, run by Cairo University.
Trial summary
This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- Probiotic yogurt and xylitol chewing gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Dec 2020
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 50 years old.
- Have sufficient cognitive ability to understand consent procedures.
- Males or Females.
- Co-operative patients.
- High caries risk patients (≥105 CFU for streptococcus mutans count)
Who cannot join
- Under antibiotic treatment
- Milk intolerant
- Consuming any other probiotic product
- Habitual consumers of xylitol products
- Use antibacterial mouthwash
- Lack of compliance
- Any systemic condition affecting salivary secretion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Antibacterial Effect of Probiotic Yogurt Against Xylitol-containing Chewing Gum on Salivary Streptococcus Mutans Count, Bacterial Adherence and Salivary pH in Geriatric Patients: A Randomized Controlled Trial
This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months.
Read the detailed description
The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months. The probiotic yogurt is (Activia; Danone, Egypt) containing Bifidobacterium (7x107 CFU/g). The subjects assigned to probiotic yogurt group will be instructed to eat 100 g of the provided yogurt 10 minutes after dinner and not to brush their teeth until one hour later. The subjects assigned to the xylitol-chewing gum group will be instructed to chew the provided gum three times daily for five minutes after each meal.
- Conditions
- Geriatric Patients
- Being tested
- Probiotic yogurt, xylitol chewing gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic yogurtDietary supplement
Probiotics are found in different dairy products including yoghurt, that are known as carriers of probiotics. These products can be easily integrated in daily meals to reduce cariogenic streptococcus mutans bacteria in dental biofilm
xylitol chewing gumDietary supplement
Xylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid
| Study group | Role | What they receive |
|---|---|---|
| xylitol chewing gum | Active comparator | Xylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid Receives: Dietary Supplement: xylitol chewing gum |
| probiotic yogurt | Experimental | Probiotics are live microorganisms that confer oral health benefits by adhering to the oral mucosa and surface of teeth as a part of the biofilm thus preventing the adhesion, colonization, and proliferation of cariogenic bacteria inhibiting the formation of pathogenic plaque Receives: Dietary Supplement: Probiotic yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
streptococcus mutans count in saliva
The samples will be transported to the laboratory and cultured on selective media (dry Mitis Salivarius Agar with potassium tellurite medium and bacitracin) after serial dilutions. The plates will be incubated at 37ºC in 5-10% CO2 jar. then number of Colony Forming Units (CFU/ml) of Mutans Streptococci in saliva will be determined
Measured: 3 months
Secondary outcomes (3)
streptococcus mutans count in plaque
The samples will then be dispersed and spread over the culture media plates (mitis salivarius-bacitracin Agar), and the plates will be incubated under aerobic conditions
Measured: 3 months
salivary pH
All the saliva samples will be tested on the same day for salivary pH using digital pH meter. The equipment will be calibrated with distilled water to reach pH 7 every time before measuring each sample
Measured: 3 months
bacterial adherence
After applying disclosing agent over teeth, standard photographic images of the maxillary and mandibular facial surfaces of teeth will be taken. Digital plaque image analysis will be used to analyze plaque coverage. Images will be converted into pixels to calculate the percentage of the tooth covered with plaque divided by the total tooth area (both tooth areas with and without plaque) as follows:
plaque area coverage = [plaque pixels / (tooth pixels + plaque pixels)] × 100 The computer analysis results will be checked for consistency and accuracy by an expert in image analysis who is blinded to the assigned treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study startJun 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric PatientsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadier Mahmoud Ahmed Gad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889015
- Sponsor's protocol ID
- probiotic versus xylitol
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antibacterial Effect of Probiotic Yogurt Against Xylitol-containing Chewing Gum on Salivary Streptococcus Mutans Count, Bacterial Adherence and Salivary pH in Geriatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03889015
- Acronym / sponsor ID
- probiotic versus xylitol
- Conditions
- Geriatric Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Mar 2019 (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.
This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months.
Detailed description
The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months. The probiotic yogurt is (Activia; Danone, Egypt) containing Bifidobacterium (7x107 CFU/g). The subjects assigned to probiotic yogurt group will be instructed to eat 100 g of the provided yogurt 10 minutes after dinner and not to brush their teeth until one hour later. The subjects assigned to the xylitol-chewing gum group will be instructed to chew the provided gum three times daily for five minutes after each meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months
| Arm | Type | Receives |
|---|---|---|
| xylitol chewing gum | Active comparator | Dietary Supplement: xylitol chewing gumXylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid |
| probiotic yogurt | Experimental | Dietary Supplement: Probiotic yogurtProbiotics are live microorganisms that confer oral health benefits by adhering to the oral mucosa and surface of teeth as a part of the biofilm thus preventing the adhesion, colonization, and proliferation of cariogenic bacteria inhibiting the formation of pathogenic plaque |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above 50 years old.
- Have sufficient cognitive ability to understand consent procedures.
- Males or Females.
- Co-operative patients.
- High caries risk patients (≥105 CFU for streptococcus mutans count)
Key exclusion criteria (7 listed)
- Under antibiotic treatment
- Milk intolerant
- Consuming any other probiotic product
- Habitual consumers of xylitol products
- Use antibacterial mouthwash
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 |
|---|---|---|
| Probiotic yogurtProbiotics are found in different dairy products including yoghurt, that are known as carriers of probiotics. These products can be easily integrated in daily meals to reduce cariogenic streptococcus mutans bacteria in dental biofilm | Dietary supplement | probiotic yogurt |
| xylitol chewing gumXylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid | Dietary supplement | xylitol chewing gum |
Primary outcome
streptococcus mutans count in saliva
Time frame: 3 months
The samples will be transported to the laboratory and cultured on selective media (dry Mitis Salivarius Agar with potassium tellurite medium and bacitracin) after serial dilutions. The plates will be incubated at 37ºC in 5-10% CO2 jar. then number of Colony Forming Units (CFU/ml) of Mutans Streptococci in saliva will be determined
3 secondary outcomes
streptococcus mutans count in plaque
Time frame: 3 months
salivary pH
Time frame: 3 months
bacterial adherence
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic yogurt and xylitol chewing gum in people with Geriatric Patients, run by Cairo University.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadier Gad, masters degree ((+202) 01067838532, hadier.mahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
streptococcus mutans count in saliva (time frame: 3 months). 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 26 Mar 2019.