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Trial record 10 of 292 for:    Sodium Fluoride OR Duraphat

Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

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ClinicalTrials.gov Identifier: NCT03877705
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Manar abd elmageed ahmed, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Saliva Altered Plaque Drug: Listerine ready tabs Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Geriatric bedridden patients
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The operator will be blinded to material and assessors will be blinded to the material assignment.
Primary Purpose: Prevention
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dissolving xylitol chewable tablets
Listerine ready tabs 3 times/day
Drug: Listerine ready tabs
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.
Other Name: Listerine chewable tablets

Active Comparator: Xylitol chewing gum
Trident original 3 times/day
Drug: Listerine ready tabs
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.
Other Name: Listerine chewable tablets




Primary Outcome Measures :
  1. Salivary bacterial count [ Time Frame: 15 days ]
    Streptococcus mutans count in saliva


Secondary Outcome Measures :
  1. Interdental plaque Bacterial count [ Time Frame: 15 days ]
    Mesial and distal Interdental plaquns streptococcus mutans count


Other Outcome Measures:
  1. Salivary pH [ Time Frame: 15 days ]
    Degree of acidity or alkalinity of salivary pH



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age range above 65 years old
  2. Bedridden patients
  3. Males or females
  4. Concious patients
  5. Co-operative patients approving to participate in the trial.
  6. Subjects who signed informed consent

Exclusion Criteria:

  1. Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
  2. Subjects who wore removable prosthesis
  3. Patients with systemic diseases that have any oral manifestations
  4. History of Smoking
  5. Allergy to any of chewing gum or tablets ingredients
  6. Evidence of tempromandibular joint disorders
  7. Presence of intraoral infections
  8. Currently using any mouth rinse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877705


Contacts
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Contact: Manar MA Abd elmageed, Resident +021287766120 dentalmena90@gmail.com
Contact: Department Of Conservative dentistry, Department +0201068685923 operative@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of dentistry Not yet recruiting
Al Manyal, Giza Governorate, Egypt, +02
Contact: Faculty Of Dentistry, Faculty    +20223634965    dentmail@dentistry.cu.edu.eg   
Contact: Department Of Conservative dentistry, Department    +0201068685923    operative@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Faculty Of Dentistry, Faculty Cairo University
  Study Documents (Full-Text)

Documents provided by Manar abd elmageed ahmed, Cairo University:
Study Protocol  [PDF] March 1, 2019


Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: Pubmed

Publications:
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Responsible Party: Manar abd elmageed ahmed, Manar abd El mageed ahmed, Cairo University
ClinicalTrials.gov Identifier: NCT03877705     History of Changes
Other Study ID Numbers: Xylitol tabs vs xylitol gum
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A paper of the research will be published internationally after results calculation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manar abd elmageed ahmed, Cairo University:
Dental Plaque , salivary pH
Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs