NCT05899075

Brief Summary

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

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 20, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

June 1, 2023

Last Update Submit

June 8, 2023

Conditions

Haemophilia

Outcome Measures

Primary Outcomes (1)

  • dental plaque

    Measure for estimating status of oral hygiene by measuring dental plaque that occurs in areas adjacent to gingival margin.

    One week

Secondary Outcomes (1)

  • Salivary levels of mutans Streptococcus

    One week

Study Arms (2)

group A

EXPERIMENTAL
Other: xylitol wipes

group B

PLACEBO COMPARATOR
Other: placebo wipes

Interventions

xylitol wipesOTHER

group A will receive xylitol wipes and group B will receive placebo wipes

group A
placebo wipesOTHER

group A will receive xylitol wipes and group B will receive placebo wipes

group B

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children on long-term antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar U

Cairo, Egypt

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hamdy Badreldin

    AlAzhar U

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BDS, Dentist at the Egyptian Ministry of Health

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

December 20, 2021

Primary Completion

October 20, 2023

Study Completion

October 25, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

EG(1)