Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

NCT ID: NCT03877705

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dissolving xylitol chewable tablets

Listerine ready tabs 3 times/day

Group Type: EXPERIMENTAL

Listerine ready tabs

Intervention Type: DRUG

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.

Xylitol chewing gum

Trident original 3 times/day

Group Type: ACTIVE_COMPARATOR

Listerine ready tabs

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Listerine chewable tablets

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Manar abd elmageed ahmed

Manar abd El mageed ahmed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faculty Of Dentistry, Faculty

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of dentistry

Al Manyal, Giza Governorate, Egypt

Countries

Egypt

Central Contacts

Manar MA Abd elmageed, Resident

Role: CONTACT

dentalmena90@gmail.com

+021287766120

Department Of Conservative dentistry, Department

Role: CONTACT

operative@dentistry.cu.edu.eg

+0201068685923

Facility Contacts

Faculty Of Dentistry, Faculty

Role: primary

dentmail@dentistry.cu.edu.eg

+20223634965

Department Of Conservative dentistry, Department

Role: backup

operative@dentistry.cu.edu.eg

+0201068685923

References

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.

Reference Type: BACKGROUND

PMID: 30123770 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Related Links

https://www.ncbi.nlm.nih.gov/m/pubmed/30123770/

Free PMC article

Other Identifiers

Xylitol tabs vs xylitol gum

Identifier Type: -

Identifier Source: org_study_id