Quality of LifeNCT03497312
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 with special healthcare need. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- full mouth rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to Jun 2019
- 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 5 to 14 years
- All sexes
- Child
Study population: Caregivers paired with their children with special health care needs attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt, will be screened for diagnosis of their chief complaint. Patients will be enrolled in this study if they are compatible with eligibility criteria.
Who may be able to join
- Age range 5 to 14 years.
- Diagnosed with physical, mental, or sensory disability (separately or combined).
- Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
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 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
Official title: Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Special Health Care Need (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 with special healthcare need.
Read the detailed description
- The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
- Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
- On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
- The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.
- Conditions
- Quality of Life
- Being tested
- full mouth rehabilitation
- Keywords
- Rehabilitation, children with disabilities, general anesthesia, Children with special healthcare need, handicapped children, full mouth rehabilitation
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 two validated questioner which are : Parental-Caregivers Perceptions Questionnaire (P-CPQ) and family impact scale(FIS). the unit of measurement is likert scale
Measured: at baseline and 6 month
Secondary outcomes (1)
Body mass
Body mass will be measure by body mass index,weight and height will be combined to report BMI in kg/m^2
Measured: at baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start15 Dec 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duha Mohammed abdelhameed, Cairo University
- Investigators
- Sheriene Ezz Eldin, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497312
- Sponsor's protocol ID
- OHRQOL in SHCNC
- Status last verified
- Jun 2018
- First submitted
- 2 Apr 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baens-Ferrer C, Roseman MM, Dumas HM, Haley SM. Parental perceptions of oral health-related quality of life for children with special needs: impact of oral rehabilitation under general anesthesia. Pediatr Dent. 2005 Mar-Apr;27(2):137-42.
PubMed 15926291Gaynor WN, Thomson WM. Changes in young children's OHRQoL after dental treatment under general anaesthesia. Int J Paediatr Dent. 2012 Jul;22(4):258-64. doi: 10.1111/j.1365-263X.2011.01190.x. Epub 2011 Oct 17.
PubMed 21999137Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent. 2003 Spring;63(2):67-72. doi: 10.1111/j.1752-7325.2003.tb03477.x.
PubMed 12816135
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. 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 With Special Health Care Need (A Before and After Study)
- ClinicalTrials.gov ID
- NCT03497312
- Acronym / sponsor ID
- OHRQOL in SHCNC
- Conditions
- Quality of Life
- Keywords
- Rehabilitation, children with disabilities, general anesthesia, Children with special healthcare need, handicapped children, full mouth rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 13 Apr 2018 (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 special healthcare need.
Detailed description
- The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
- Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
- On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
- The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Caregivers paired with their children with special health care needs attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt, will be screened for diagnosis of their chief complaint. Patients will be enrolled in this study if they are compatible with eligibility criteria.
Key inclusion criteria (3 listed)
- Age range 5 to 14 years.
- Diagnosed with physical, mental, or sensory disability (separately or combined).
- Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
Key exclusion criteria (4 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 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 |
|---|---|---|
| full mouth rehabilitationfull mouth rehabilitation under general anesthesia | Procedure or surgery | – |
Primary outcome
Oral health related quality of life (OHRQOL)
Time frame: at baseline and 6 month
Oral health related quality of life (OHRQOL) will be measured by two validated questioner which are : Parental-Caregivers Perceptions Questionnaire (P-CPQ) and family impact scale(FIS). the unit of measurement is likert scale
1 secondary outcome
Body mass
Time frame: at baseline and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Background: PubMed 15926291Baens-Ferrer C, Roseman MM, Dumas HM, Haley SM. Parental perceptions of oral health-related quality of life for children with special needs: impact of oral rehabilitation under general anesthesia. Pediatr Dent. 2005 Mar-Apr;27(2):137-42.
- Background: PubMed 21999137Gaynor WN, Thomson WM. Changes in young children's OHRQoL after dental treatment under general anaesthesia. Int J Paediatr Dent. 2012 Jul;22(4):258-64. doi: 10.1111/j.1365-263X.2011.01190.x. Epub 2011 Oct 17.
- Background: PubMed 12816135Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent. 2003 Spring;63(2):67-72. doi: 10.1111/j.1752-7325.2003.tb03477.x.
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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.
Sheriene Ezz Eldin, 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 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 13 Jun 2018. 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 DUHA M ABDELHAMEED, MASTER (00201112096880, duha.hameed.dh@gmail.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: at baseline and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497312, which also lists 3 linked publications.
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 13 Jun 2018.