Pediatric DentistryNCT05146271
Change in Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Down Syndrome
An observational study of Pediatric Dentistry, run by Cairo University.
Trial summary
To assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome . Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dentistry
- What is being tested?
- Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 30 Sep 2022
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Group of Egyptian Children with Down Syndrome
Who may be able to join
- Inclusion Criteria Age range 1 to 15 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
- Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
Who cannot join
- Inclusion Criteria Age range 3 to 14 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
- Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
Trial locations and contacts
No sites are listed yet.
About this study
To assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
Read the detailed description
Dental treatment under GA provides a safe approach and has significant positive effects on quality of life for children with down syndrome who cannot accept normal treatment. Oral health related quality of life is measured in relation to how the mouth and teeth affect physical, psychological and social well-being and daily activities such as eating, chewing, swallowing, speaking, playing, learning, happiness, embarrassment, and social interactions (Jabarifar et al., 2009). Jankauskiene et al., 2010 conducted a systematic review concluded that "Oral rehabilitation under GA results in immediate improvement of the children's oral health and physical, emotional and social quality of life. It also has a positive impact on the family". Dental caries is a common condition amongst young children which negatively impacts on their quality of life. children with down syndrome who have an increased risk of developing caries due to various reasons: limited oral healthcare, difficultty in dental services,un stable diet, the high sugar contents in their medications and low salivary secretion(Peerbhay \& Titinchi, 2014).
- Conditions
- Pediatric Dentistry
- Being tested
- Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndromeProcedure or surgery
Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
Measured: Baseline
Secondary outcomes (1)
Change in family conflict scale
Change in family conflict
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DentistryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 21 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mmohamed ramadan mohamed ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146271
- Sponsor's protocol ID
- Change in quality of life
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 6 Dec 2021
- 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 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05146271
- Acronym / sponsor ID
- Change in quality of life
- Conditions
- Pediatric Dentistry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Dec 2021 (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.
To assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
Detailed description
Dental treatment under GA provides a safe approach and has significant positive effects on quality of life for children with down syndrome who cannot accept normal treatment. Oral health related quality of life is measured in relation to how the mouth and teeth affect physical, psychological and social well-being and daily activities such as eating, chewing, swallowing, speaking, playing, learning, happiness, embarrassment, and social interactions (Jabarifar et al., 2009). Jankauskiene et al., 2010 conducted a systematic review concluded that "Oral rehabilitation under GA results in immediate improvement of the children's oral health and physical, emotional and social quality of life. It also has a positive impact on the family". Dental caries is a common condition amongst young children which negatively impacts on their quality of life. children with down syndrome who have an increased risk of developing caries due to various reasons: limited oral healthcare, difficultty in dental services,un stable diet, the high sugar contents in their medications and low salivary secretion(Peerbhay \& Titinchi, 2014).
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Group of Egyptian Children with Down Syndrome
Key inclusion criteria (4 listed)
- Inclusion Criteria Age range 1 to 15 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
- Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
Key exclusion criteria (4 listed)
- Inclusion Criteria Age range 3 to 14 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
- Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
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 |
|---|---|---|
| Complete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndromeComplete mouth rehabilitation under general anesthesia in a group of Egyptian children with Down syndrome | Procedure or surgery | – |
Primary outcome
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
Time frame: Baseline
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .
1 secondary outcome
Change in family conflict scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Dentistry, run by Cairo University.
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 4 inclusion and 4 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Mohamed Ramadan, Bachalor (0201273215905, mohamedramadan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome . (time frame: Baseline). 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 6 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.