Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA

June 11, 2018 updated by: Duha Mohammed abdelhameed, Cairo University

Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Special Health Care Need (A Before and After Study)

To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with special healthcare need.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
  • Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
  • On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
  • The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.

Study Type

Observational

Enrollment (Anticipated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caregivers paired with their children with special health care needs attending Pediatric Dentistry and Dental Public Health department, faculty of dentistry, Cairo University Egypt, will be screened for diagnosis of their chief complaint. Patients will be enrolled in this study if they are compatible with eligibility criteria.

Description

Inclusion Criteria:

  1. Age range 5 to 14 years.
  2. Diagnosed with physical, mental, or sensory disability (separately or combined).
  3. Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.

Exclusion Criteria:

  1. Participation in any other concurrent clinical trials.
  2. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
  3. Children whose parents had no home or mobile phone to enable post-operative contact.
  4. Parent that will not sign the consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health related quality of life (OHRQOL)
Time Frame: at baseline and 6 month
Oral health related quality of life (OHRQOL) will be measured by two validated questioner which are : Parental-Caregivers Perceptions Questionnaire (P-CPQ) and family impact scale(FIS). the unit of measurement is likert scale
at baseline and 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass
Time Frame: at baseline and 6 month
Body mass will be measure by body mass index,weight and height will be combined to report BMI in kg/m^2
at baseline and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Sheriene Ezz Eldin, PHD, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHRQOL in SHCNC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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