HaemophiliaNCT05899075
Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children
A study testing xylitol wipes in people with Haemophilia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate xylitol wipes as an oral hygiene protocol for haemophilic children Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Haemophilia
- What is being tested?
- xylitol wipes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemophilic children A or B with No other systemic diseases.
- Aged (6-12 years).
- Co-operative.
Who cannot join
- Children on long-term antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Haemophilia
- Being tested
- xylitol wipes, placebo wipes
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylitol wipesOther
group A will receive xylitol wipes and group B will receive placebo wipes
placebo wipesOther
group A will receive xylitol wipes and group B will receive placebo wipes
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Other: xylitol wipes |
| group B | Placebo comparator | Not described Receives: Other: placebo wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental plaque
Measure for estimating status of oral hygiene by measuring dental plaque that occurs in areas adjacent to gingival margin.
Measured: One week
Secondary outcomes (1)
Salivary levels of mutans Streptococcus
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start20 Dec 2021
- Primary completion20 Oct 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmageed Mohamed Nazmy Bassiouny Mohamed Harras, Al-Azhar University
- Investigators
- Hamdy Badreldin, Study director, AlAzhar U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899075
- Sponsor's protocol ID
- 687/3906
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05899075
- Acronym / sponsor ID
- 687/3906
- Conditions
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate xylitol wipes as an oral hygiene protocol for haemophilic children
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: xylitol wipes |
| group B | Placebo comparator | Other: placebo wipes |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hemophilic children A or B with No other systemic diseases.
- Aged (6-12 years).
- Co-operative.
Key exclusion criteria (1 listed)
- Children on long-term antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xylitol wipesgroup A will receive xylitol wipes and group B will receive placebo wipes | Other | group A |
| placebo wipesgroup A will receive xylitol wipes and group B will receive placebo wipes | Other | group B |
Primary outcome
dental plaque
Time frame: One week
Measure for estimating status of oral hygiene by measuring dental plaque that occurs in areas adjacent to gingival margin.
1 secondary outcome
Salivary levels of mutans Streptococcus
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdy Badreldin study director
AlAzhar U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xylitol wipes in people with Haemophilia, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental plaque (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.