Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

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.

Study Overview

• Status: Unknown
• Conditions: Plaque; Saliva Altered
• Intervention / Treatment: Drug: Listerine ready tabs

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 Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Manar MA Abd elmageed, Resident; Phone Number: +021287766120; Email: dentalmena90@gmail.com
• Study Contact Backup: Name: Department Of Conservative dentistry, Department; Phone Number: +0201068685923; Email: operative@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Giza Governorate
    • Al Manyal, Giza Governorate, Egypt, +02
      • Faculty of Dentistry
      • Contact: Department Of Conservative dentistry, Department; Phone Number: +0201068685923; Email: operative@dentistry.cu.edu.eg
      • Contact: Faculty Of Dentistry, Faculty; Phone Number: +20223634965; Email: dentmail@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Listerine chewable tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary bacterial count	Streptococcus mutans count in saliva	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interdental plaque Bacterial count	Mesial and distal Interdental plaquns streptococcus mutans count	15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary pH	Degree of acidity or alkalinity of salivary pH	15 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Faculty Of Dentistry, Faculty, Cairo University

Publications and helpful links

General 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.

Helpful Links

• Free PMC article

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Dental Plaque , salivary pH
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: Xylitol tabs vs xylitol gum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: A paper of the research will be published internationally after results calculation

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: Pubmed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No