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

NCT04861675 | Unknown

• 1 other identifier: 14422019465983
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Oral hygiene status

  6 months

Other Outcomes (1)

• Body mass index

  6 months

Study Arms (1)

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

Full mouth rehabilitation under general anaesethia PROCEDURE

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,

Prospective follow up cohort study

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Intellectual disabled children with carious teeth

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: July 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share