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NCT03877705 Clinical Trial

Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

Plaque Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03877705
Other study ID # Xylitol tabs vs xylitol gum
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date September 1, 2019
Est. completion date January 1, 2021

Study information
Verified date March 2019
Source Cairo University
Contact Manar MA Abd elmageed, Resident
Phone +021287766120
Email dentalmena90@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 98
Est. completion date January 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Egypt Faculty of dentistry Al Manyal Giza Governorate

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Salivary pH Degree of acidity or alkalinity of salivary pH 15 days
Primary Salivary bacterial count Streptococcus mutans count in saliva 15 days
Secondary Interdental plaque Bacterial count Mesial and distal Interdental plaquns streptococcus mutans count 15 days
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