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Clinical Trials/NCT03877705
NCT03877705UnknownEarly Phase 1

Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial

Cairo University1 site in 1 country98 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Enrollment
98
Locations
1
Primary Endpoint
Salivary bacterial count

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

The operator will be blinded to material and assessors will be blinded to the material assignment.

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Dissolving xylitol chewable tablets

Experimental

Listerine ready tabs 3 times/day

Intervention: Listerine ready tabs (Drug)

Xylitol chewing gum

Active Comparator

Trident original 3 times/day

Intervention: Listerine ready tabs (Drug)

Outcomes

Primary Outcomes

Salivary bacterial count

Time Frame: 15 days

Streptococcus mutans count in saliva

Secondary Outcomes

  • Interdental plaque Bacterial count(15 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manar abd elmageed ahmed

Manar abd El mageed ahmed

Cairo University

Study Sites (1)

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