Quality of LifeNCT05127655
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA
An observational study of Quality of Life, 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 below 5 years Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- full mouth rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 May 2023
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Caregivers paired with their children attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt
Who may be able to join
- Age range 2 to 5 years .
- Children with untreated early childhood caries .
- Children who will undergo dental treatment under general anesthesia.
Who cannot join
- 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 with special healthcare needs.
- Children whose parents had no home or mobile phone to enable postoperative contact.
- Parent that will not sign the consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children Below 5 Years Old (A Before and After Study)
To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children below 5 years
- Conditions
- Quality of Life
- Being tested
- full mouth rehabilitation
- Keywords
- Rehabilitation, full mouth rehabilitation, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full mouth rehabilitationProcedure or surgery
full mouth rehabilitation under general anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related quality of life (OHRQOL)
Oral health related quality of life (OHRQOL) will be measured by validated questionnaire which is : Early Childhood Oral Health Impact Scale (ECOHIS) .
the unit of measurement is likert scale.
Measured: change from baseline oral health related quality of life at 6 months
Secondary outcomes (1)
Body mass index
Children's weights will be measured in kilograms and heights in meters .Body max index (BMI) will be calculated using this formula: BMI = weight (kg) / height (m)² to report BMI in kg/m^2
Measured: change of baseline body mass at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyman Sheikh Eldin Mokhtar, Cairo University
- Investigators
- Fatima Korany, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127655
- Sponsor's protocol ID
- OHRQOL in 5 years children
- Status last verified
- Oct 2021
- First submitted
- 9 Nov 2018
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children Below 5 Years Old (A Before and After Study)
- ClinicalTrials.gov ID
- NCT05127655
- Acronym / sponsor ID
- OHRQOL in 5 years children
- Conditions
- Quality of Life
- Keywords
- Rehabilitation, full mouth rehabilitation, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 19 Nov 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 below 5 years
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Caregivers paired with their children attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt
Key inclusion criteria (3 listed)
- Age range 2 to 5 years .
- Children with untreated early childhood caries .
- Children who will undergo dental treatment under general anesthesia.
Key exclusion criteria (5 listed)
- 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 with special healthcare needs.
- Children whose parents had no home or mobile phone to enable postoperative 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 |
|---|---|---|
| full mouth rehabilitationfull mouth rehabilitation under general anesthesia | Procedure or surgery | – |
Primary outcome
Oral health related quality of life (OHRQOL)
Time frame: change from baseline oral health related quality of life at 6 months
Oral health related quality of life (OHRQOL) will be measured by validated questionnaire which is : Early Childhood Oral Health Impact Scale (ECOHIS) . the unit of measurement is likert scale.
1 secondary outcome
Body mass index
Time frame: change of baseline body mass at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Related trials for Quality of Life
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
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.
Fatima Korany, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, 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 3 inclusion and 5 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 19 Nov 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 eyman sh mokhtar, master (00201114540003, emanmokhtar129@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health related quality of life (OHRQOL) (time frame: change from baseline oral health related quality of life at 6 months). 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 19 Nov 2021.