Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in CSHCN Following Dental Treatment Under General Anaesthesia

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; General Anesthesia; Body Mass Index; Children With Special Health Care Needs
• Intervention / Treatment: Procedure: Full mouth rehabilitation under general anaesethia

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

• Study Type: Observational
• Enrollment (Anticipated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral hygiene status	Plaquei ndex (Löe and Silness, 1963)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	weight and height will be combined to report BMI in kg/m^2	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 14422019465983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No