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Status unknownNCT04861675Updated Apr 27, 2021

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 in Quality of Life, General Anesthesia and Children With Special Health Care Needs, sponsored by Cairo University. Status unknown. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
3 Years to 9 Years
Sex
All
01

Study 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 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.

  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
02

Conditions studied

  • Quality of Life
  • General Anesthesia
  • Children With Special Health Care Needs
  • Body Mass Index
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,911 studies on the registry; 1,443 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Intellectual disabled children with carious teeth

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: Full mouth rehabilitation under general anaesethia

Interventions

  • ProcedureFull mouth rehabilitation under general anaesethia

    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,

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Oral hygiene status

    Plaquei ndex (Löe and Silness, 1963)

    Time frame: 6 months

Other outcomes

  1. Body mass index

    weight and height will be combined to report BMI in kg/m\^2

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04861675
Lead sponsor
Cairo University
Responsible party
Mahy Abdel Raouf Aly Kamar (Principal Investigator, Cairo University) — Principal investigator
First posted
Apr 27, 2021
Start date
Jul 2021 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
Apr 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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