Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

Early Phase 1

• Conditions: Saliva Altered; Plaque
• Interventions: Drug: Listerine ready tabs

• Registration Number: NCT03877705
• Lead Sponsor: Cairo University

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-18
• Last Update Posted: 2019-03-18
• Study Start: 2019-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylitol chewing gum	Listerine ready tabs	Trident original 3 times/day
Dissolving xylitol chewable tablets	Listerine ready tabs	Listerine ready tabs 3 times/day

Primary Outcome Measures

Name	Time	Method
Salivary bacterial count	15 days	Streptococcus mutans count in saliva

Secondary Outcome Measures

Name	Time	Method
Interdental plaque Bacterial count	15 days	Mesial and distal Interdental plaquns streptococcus mutans count

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Al Manyal, Giza Governorate, Egypt