NCT03877705

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 12, 2019

Last Update Submit

March 14, 2019

Conditions

Saliva AlteredPlaque

Keywords

Dental Plaque , salivary pH

Outcome Measures

Primary Outcomes (1)

  • Salivary bacterial count

    Streptococcus mutans count in saliva

    15 days

Secondary Outcomes (1)

  • Interdental plaque Bacterial count

    15 days

Other Outcomes (1)

  • Salivary pH

    15 days

Study Arms (2)

Dissolving xylitol chewable tablets

EXPERIMENTAL

Listerine ready tabs 3 times/day

Drug: Listerine ready tabs

Xylitol chewing gum

ACTIVE COMPARATOR

Trident original 3 times/day

Drug: Listerine ready tabs

Interventions

Listerine ready tabsDRUG

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.

Also known as: Listerine chewable tablets
Dissolving xylitol chewable tabletsXylitol chewing gum

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Al Manyal, Giza Governorate, +02, Egypt

Location

Related 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.

    PMID: 30123770BACKGROUND

Related Links

MeSH Terms

Conditions

Plaque, AmyloidDental Plaque

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Faculty Of Dentistry, Faculty

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Manar MA Abd elmageed, Resident

CONTACT

+021287766120dentalmena90@gmail.com

Department Of Conservative dentistry, Department

CONTACT

+0201068685923operative@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The operator will be blinded to material and assessors will be blinded to the material assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Geriatric bedridden patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manar abd El mageed ahmed

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 18, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

January 1, 2021

Last Updated

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

A paper of the research will be published internationally after results calculation

Available IPD Datasets

Individual Participant Data Set (Pubmed)Access

Locations

EG(1)