Saliva AlteredEarly Phase 1NCT03877705
Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients
A Early Phase 1 study testing Listerine ready tabs in people with Saliva Altered and Plaque, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered, Plaque
- What is being tested?
- Listerine ready tabs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Jan 2021
- Phase
- Early Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age range above 65 years old
- Bedridden patients
- Males or females
- Concious patients
- Co-operative patients approving to participate in the trial.
- Subjects who signed informed consent
Who cannot join
- Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
- Subjects who wore removable prosthesis
- Patients with systemic diseases that have any oral manifestations
- History of Smoking
- Allergy to any of chewing gum or tablets ingredients
- Evidence of tempromandibular joint disorders
- Presence of intraoral infections
- Currently using any mouth rinse
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry
Al Manyal, Giza Governorate, +02
Faculty Of Dentistry, Faculty, +20223634965, dentmail@dentistry.cu.edu.eg
Department Of Conservative dentistry, Department, +0201068685923, operative@dentistry.cu.edu.eg
About this study
Official title: Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial
This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.
Read the detailed description
This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin
- Conditions
- Saliva Altered, Plaque
- Being tested
- Listerine ready tabs
- Keywords
- Dental Plaque , salivary pH
- Medical subject headings
- Plaque, Amyloid, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine ready tabsDrug
Also called Listerine chewable tablets
Technically, it's a rectangular-shaped, bilayer-compressed tablet that once chewed, creates just enough liquid to swish around your mouth to get a whole-mouth clean feeling.As manufacture claimed the tablet is easy to use just in three simple steps: chew (to activate), swish (to clean), then swallow as unlike mouthwashes which may contain alcohol and other ingredients not intended for ingestion, Listerine Ready Tabs are alcohol-free and safe to swallow which is highly suitable for bedridden patients.
| Study group | Role | What they receive |
|---|---|---|
| Dissolving xylitol chewable tablets | Experimental | Listerine ready tabs 3 times/day Receives: Drug: Listerine ready tabs |
| Xylitol chewing gum | Active comparator | Trident original 3 times/day Receives: Drug: Listerine ready tabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary bacterial count
Streptococcus mutans count in saliva
Measured: 15 days
Secondary outcomes (1)
Interdental plaque Bacterial count
Mesial and distal Interdental plaquns streptococcus mutans count
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Saliva AlteredStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Geriatric bedridden patients
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar abd elmageed ahmed, Cairo University
- Investigators
- Faculty Of Dentistry, Faculty, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877705
- Sponsor's protocol ID
- Xylitol tabs vs xylitol gum
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A paper of the research will be published internationally after results calculation
Publications
Oza S, Patel K, Bhosale S, Mitra R, Gupta R, Choudhary D. To Determine the Effect of Chewing Gum Containing Xylitol and Sorbitol on Mutans Streptococci and Lactobacilli Count in Saliva, Plaque, and Gingival Health and to Compare the Efficacy of Chewing Gums. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):354-360. doi: 10.4103/jispcd.JISPCD_54_18. Epub 2018 Jul 18.
PubMed 30123770
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03877705
- Acronym / sponsor ID
- Xylitol tabs vs xylitol gum
- Conditions
- Saliva Altered, Plaque
- Keywords
- Dental Plaque , salivary pH
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 18 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 effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.
Detailed description
This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Geriatric bedridden patients
| Arm | Type | Receives |
|---|---|---|
| Dissolving xylitol chewable tablets | Experimental | Drug: Listerine ready tabsListerine ready tabs 3 times/day |
| Xylitol chewing gum | Active comparator | Drug: Listerine ready tabsTrident original 3 times/day |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age range above 65 years old
- Bedridden patients
- Males or females
- Concious patients
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (8 listed)
- Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
- Subjects who wore removable prosthesis
- Patients with systemic diseases that have any oral manifestations
- History of Smoking
- Allergy to any of chewing gum or tablets ingredients
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 |
|---|---|---|
| Listerine ready tabsAlso: Listerine chewable tabletsTechnically, it's a rectangular-shaped, bilayer-compressed tablet that once chewed, creates just enough liquid to swish around your mouth to get a whole-mouth clean feeling.As manufacture claimed the tablet is easy to use just in three simple steps: chew (to activate), swish (to clean), then swallow as unlike mouthwashes which may contain alcohol and other ingredients not intended for ingestion, Listerine Ready Tabs are alcohol-free and safe to swallow which is highly suitable for bedridden patients. | Drug | Dissolving xylitol chewable tablets, Xylitol chewing gum |
Primary outcome
Salivary bacterial count
Time frame: 15 days
Streptococcus mutans count in saliva
1 secondary outcome
Interdental plaque Bacterial count
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 30123770Oza S, Patel K, Bhosale S, Mitra R, Gupta R, Choudhary D. To Determine the Effect of Chewing Gum Containing Xylitol and Sorbitol on Mutans Streptococci and Lactobacilli Count in Saliva, Plaque, and Gingival Health and to Compare the Efficacy of Chewing Gums. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):354-360. doi: 10.4103/jispcd.JISPCD_54_18. Epub 2018 Jul 18.
- Free PMC articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. A paper of the research will be published internationally after results calculation
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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.
Faculty Of Dentistry, Faculty study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Listerine ready tabs in people with Saliva Altered and Plaque, 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 6 inclusion and 8 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 18 Mar 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Manar MA Abd elmageed, Resident (+021287766120, dentalmena90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary bacterial count (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877705, which also lists 1 linked publication.
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 18 Mar 2019.