Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04861675
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Mahy Abdel Raouf Aly Kamar, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Quality of Life General Anesthesia Children With Special Health Care Needs Body Mass Index 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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,


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in oral health related quality of life. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Oral hygiene status [ Time Frame: 6 months ]
    Plaquei ndex (Löe and Silness, 1963)


Other Outcome Measures:
  1. Body mass index [ Time Frame: 6 months ]
    weight and height will be combined to report BMI in kg/m^2


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mahy Abdel Raouf Aly Kamar, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04861675    
Other Study ID Numbers: 14422019465983
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No