Quality of LifeNCT04861675
Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in CSHCN Following Dental Treatment Under General Anaesthesia
An observational study of Quality of Life and General Anesthesia, run by Cairo University.
Trial summary
evaluation of the impact of dental treatment under GA on oral health-related quality of life (OHRQoL) in children with SHCN with severe dental caries with Assessment in change in oral health status and the impact on children's weight (Wt), height (Ht), Body Mass Index (BMI). Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Quality of Life, General Anesthesia, Children With Special Health Care Needs
- What is being tested?
- Full mouth rehabilitation under general anaesethia
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Jul 2022
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.
Who may be able to join
- Intellectual disabled children with carious teeth
Who cannot join
- Healthy children
- children with physical special needs.
- Refusal of participation.
- Participation in any other concurrent clinical trials.
- Presence of any serious medical condition or transmissible diseases such as hepatitis , AIDS or malignancies.
- Children whose parents refuse to sign the consent or have no phone no. to enable post-operative contact.
About this study
Official title: Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in Egyptian Children With Special Health Care Needs Following Dental Treatment Under General Anaesthesia
evaluation of the impact of dental treatment under GA on oral health-related quality of life (OHRQoL) in children with SHCN with severe dental caries with Assessment in change in oral health status and the impact on children's weight (Wt), height (Ht), Body Mass Index (BMI).
Read the detailed description
The study consisted of clinical dental examinations performed at the time of DGA and at the six-month recall, along with OHRQoL questionnaires and data drawn from the patients' files.
- OHRQoL will be assessed with the early childhood oral health impact scale (ECHOIS) that is composed of items which assess the effect of oral health condition on different aspects of life of the patient .
- Children with Mental special health care needs will be recruited from G.A unit in department of pediatric dentistry , faculty of oral and dental medicine cairo university.
- Data will be collected for each of the study participants included age, gender ,Medical (type of disability and history of disability) , dental histories and clinical findings were correlated accordingly together with determining the type of disability, anthropometric measures (HT, WT,BMI) that will be measured at baseline and after 3 to 6 months from dental treatment under general anesthesia.
- The parent or the care giver will be taken as a surrogate measure that will self-complete (ECOHIS) Before and after treatment with follow up after 3 \& 6 months to assess and evaluate children's OHRQoL and anthropometric measures update.
- Each GA session included a comprehensive clinical dental examination and full dental rehabilitation. The Silness-Loe plaque index (PI) was used to assess oral hygiene status. That was measured in the four levels of distal facial, mesial-facial, facial, and lingual of first molars, first premolar and central in each quadrant using mirror and probe.
- The plaque index was obtained by adding the figures of the four above-mentioned areas of each teeth and dividing it by 4 before recording it in the examination form
- Parents/ caregiver will be asked to consider the last 6 months when responding the questions After ttt , Examine effect of oral rehabilitation under GA and its effect on improving quality of life ( pain , eating problems, sleeping problems ,growth parameters as (Wt, Ht, BMI) and any postoperative complications as postoperative pain and pharynx discomfort or fever
- Conditions
- Quality of Life, General Anesthesia, Children With Special Health Care Needs, Body Mass Index
- Being tested
- Full mouth rehabilitation under general anaesethia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full mouth rehabilitation under general anaesethiaProcedure or surgery
Assessment of change in oral health related quality of life , body growth status and oral hygiene status for children with special health care needs after full mouth rehabilitation under general anesethia,
| Study group | Role | What they receive |
|---|---|---|
| Prospective follow up cohort study | Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene status and Body Growth in Egyptian Children with Special Health Care Needs following Dental Treatment under General Anaesthesia Receives: Procedure: Full mouth rehabilitation under general anaesethia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral health related quality of life.
Early childhood oral health impact scale , A total score of ECOHIS ranging from 0 to 52 was calculated as a simple sum of the responses. Higher scores representing a greater oral health impact and/or poorer OHRQoL.
Measured: 6 months
Secondary outcomes (1)
Oral hygiene status
Plaquei ndex (Löe and Silness, 1963)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startJul 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahy Abdel Raouf Aly Kamar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861675
- Sponsor's protocol ID
- 14422019465983
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in Egyptian Children With Special Health Care Needs Following Dental Treatment Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT04861675
- Acronym / sponsor ID
- 14422019465983
- Conditions
- Quality of Life, General Anesthesia, Children With Special Health Care Needs, Body Mass Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Apr 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.
evaluation of the impact of dental treatment under GA on oral health-related quality of life (OHRQoL) in children with SHCN with severe dental caries with Assessment in change in oral health status and the impact on children's weight (Wt), height (Ht), Body Mass Index (BMI).
Detailed description
The study consisted of clinical dental examinations performed at the time of DGA and at the six-month recall, along with OHRQoL questionnaires and data drawn from the patients' files.
- OHRQoL will be assessed with the early childhood oral health impact scale (ECHOIS) that is composed of items which assess the effect of oral health condition on different aspects of life of the patient .
- Children with Mental special health care needs will be recruited from G.A unit in department of pediatric dentistry , faculty of oral and dental medicine cairo university.
- Data will be collected for each of the study participants included age, gender ,Medical (type of disability and history of disability) , dental histories and clinical findings were correlated accordingly together with determining the type of disability, anthropometric measures (HT, WT,BMI) that will be measured at baseline and after 3 to 6 months from dental treatment under general anesthesia.
- The parent or the care giver will be taken as a surrogate measure that will self-complete (ECOHIS) Before and after treatment with follow up after 3 \& 6 months to assess and evaluate children's OHRQoL and anthropometric measures update.
- Each GA session included a comprehensive clinical dental examination and full dental rehabilitation. The Silness-Loe plaque index (PI) was used to assess oral hygiene status. That was measured in the four levels of distal facial, mesial-facial, facial, and lingual of first molars, first premolar and central in each quadrant using mirror and probe.
- The plaque index was obtained by adding the figures of the four above-mentioned areas of each teeth and dividing it by 4 before recording it in the examination form
- Parents/ caregiver will be asked to consider the last 6 months when responding the questions After ttt , Examine effect of oral rehabilitation under GA and its effect on improving quality of life ( pain , eating problems, sleeping problems ,growth parameters as (Wt, Ht, BMI) and any postoperative complications as postoperative pain and pharynx discomfort or fever
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective follow up cohort study | – | Procedure: Full mouth rehabilitation under general anaesethiaAssessment of Changes in Oral Health-related Quality of Life , Oral Hygiene status and Body Growth in Egyptian Children with Special Health Care Needs following Dental Treatment under General Anaesthesia |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.
Key inclusion criteria (1 listed)
- Intellectual disabled children with carious teeth
Key exclusion criteria (6 listed)
- Healthy children
- children with physical special needs.
- Refusal of participation.
- Participation in any other concurrent clinical trials.
- Presence of any serious medical condition or transmissible diseases such as hepatitis , AIDS or malignancies.
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 rehabilitation under general anaesethiaAssessment of change in oral health related quality of life , body growth status and oral hygiene status for children with special health care needs after full mouth rehabilitation under general anesethia, | Procedure or surgery | Prospective follow up cohort study |
Primary outcome
Change in oral health related quality of life.
Time frame: 6 months
Early childhood oral health impact scale , A total score of ECOHIS ranging from 0 to 52 was calculated as a simple sum of the responses. Higher scores representing a greater oral health impact and/or poorer OHRQoL.
1 secondary outcome
Oral hygiene status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and General Anesthesia, 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 1 inclusion and 6 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 27 Apr 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?
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?
Change in oral health related quality of life. (time frame: 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 27 Apr 2021.