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

NCT03497312 | Unknown

• 1 other identifier: OHRQOL in SHCNC
• Study Type: observational
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Quality of Life

Keywords

Rehabilitation; children with disabilities; general anesthesia; Children with special healthcare need; handicapped children; full mouth rehabilitation

Outcome Measures

Primary Outcomes (1)

• Oral health related quality of life (OHRQOL)

  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 Outcomes (1)

• Body mass

  at baseline and 6 month

Interventions

full mouth rehabilitation PROCEDURE

full mouth rehabilitation under general anesthesia

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Baens-Ferrer C, Roseman MM, Dumas HM, Haley SM. Parental perceptions of oral health-related quality of life for children with special needs: impact of oral rehabilitation under general anesthesia. Pediatr Dent. 2005 Mar-Apr;27(2):137-42.

  PMID: 15926291 BACKGROUND

• Gaynor WN, Thomson WM. Changes in young children's OHRQoL after dental treatment under general anaesthesia. Int J Paediatr Dent. 2012 Jul;22(4):258-64. doi: 10.1111/j.1365-263X.2011.01190.x. Epub 2011 Oct 17.

  PMID: 21999137 BACKGROUND

• Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Measuring parental perceptions of child oral health-related quality of life. J Public Health Dent. 2003 Spring;63(2):67-72. doi: 10.1111/j.1752-7325.2003.tb03477.x.

  PMID: 12816135 BACKGROUND

Study Officials

• Sheriene Ezz Eldin, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

DUHA M ABDELHAMEED, MASTER

CONTACT

00201112096880; duha.hameed.dh@gmail.com

FATIMA KORANY, PHD

CONTACT

00201006753265; fatmadent@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Duha Mohammed Abdelhameed pedodontist principle investigator

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 13, 2018
• Study Start: December 15, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 13, 2018

Record last verified: 2018-06