Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children

Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children: A Randomized Clinical Trial

The purpose of this study is to evaluate xylitol wipes as an oral hygiene protocol for haemophilic children

Study Overview

• Status: Active, not recruiting
• Conditions: Haemophilia
• Intervention / Treatment: Other: xylitol wipes; Other: placebo wipes

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AlAzhar U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hemophilic children A or B with No other systemic diseases.
• Aged (6-12 years).
• Co-operative.

Exclusion Criteria:

• Children on long-term antibiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A	Other: xylitol wipes; group A will receive xylitol wipes and group B will receive placebo wipes
Placebo Comparator: group B	Other: placebo wipes; group A will receive xylitol wipes and group B will receive placebo wipes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dental plaque	Measure for estimating status of oral hygiene by measuring dental plaque that occurs in areas adjacent to gingival margin.	One week

Secondary Outcome Measures

Outcome Measure	Time Frame
Salivary levels of mutans Streptococcus	One week

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Hamdy Badreldin, AlAzhar U

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): October 20, 2023
• Study Completion (Estimated): October 25, 2023

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 687/3906

Drug and device information, study documents

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