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

NCT ID: NCT03497312

Last Updated: 2018-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-15

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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full mouth rehabilitation

full mouth rehabilitation under general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Duha Mohammed abdelhameed

Doctor Duha Mohammed Abdelhameed pedodontist principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheriene Ezz Eldin, PHD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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DUHA M ABDELHAMEED, MASTER

Role: CONTACT

00201112096880

FATIMA KORANY, PHD

Role: CONTACT

00201006753265

References

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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.

Reference Type BACKGROUND
PMID: 15926291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21999137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12816135 (View on PubMed)

Other Identifiers

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OHRQOL in SHCNC

Identifier Type: -

Identifier Source: org_study_id

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