Clinical trial NCT04861675: Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in CSHCN Following Dental Treatment Under General Anaesthesia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
General Anesthesia
Children With Special Health Care Needs
Body Mass Index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.

Brief 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).

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.

1. 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 .
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
7. 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

Eligibility criteria: Inclusion Criteria:

* Intellectual disabled children with carious teeth

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in oral health related quality of life.
timeFrame: 6 months
Secondary outcomes:
measure: Oral hygiene status
timeFrame: 6 months
Other outcomes:
measure: Body mass index
timeFrame: 6 months
Locations:
Study officials:
References: