National Treatment Approach Versus Standardized Treatment Protocol to Manage Patients With Cleft Lip and Palate: a Cross Sectional Study

November 5, 2023 updated by: Hana Adel Adawy, Cairo University
The main objective of this study is to provide data about treatment protocols for CLP patients in Egypt, and compare it to the management protocol suggested by the ACPA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a cross-setional survey to gather data concerning the current CL/P situation in our country.

The main objectives of this study are

  1. To identify if the healthcare providers in Egypt work in cleft centers or teams
  2. To assess if the healthcare providers are aware of the interdisciplinary team-based treatment approach that should be followed for CLP patients' management.
  3. To provide data about the cleft lip and palate management protocols that are being followed in Egypt.
  4. Evaluation of the current status of cleft care and experiences of the health care providers involved in the management of the CLP in Egypt including Orthodontists, OMFS, Otolaryngologists, Plastic Surgeons, Speech therapists, Dentists, Psychiatrists, Psychologists, Pediatricians, Nurses and Social Workers.
  5. Identify the presence or absence of cleft centers in our country.
  6. Identify the presence or absence or organized healthcare services for the CLP patients in terms of parents' awareness about the condition and its management, as well as the presence of medical referrals between the specialists.
  7. Reporting the patients/parents' experiences throughout their treatment journey.
  8. Highlight the obstacles that could be faced by the health care providers as well as the patients along the treatment journey.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • CairoU

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

all the specialists involved in the management of cleft lip and palate patients as well as cleft lip and palate adult patients will be involved in the questionnaire

Description

Inclusion Criteria:

  • • A sample of CLP patients of varying age groups: (Neonate and Infant (Birth -2 years of age), Primary Dentition Stage (2 to 6 Years of Age), Permanent Dentition Stage)

    • CLP patients' parents will be included to answer questions involving CLP infants and adolescents
    • Paediatric dentists
    • Paediatricians
    • GP dentists
    • Oral and maxillofacial surgeons
    • Plastic surgeons
    • Orthodontists
    • Nurses
    • Speech therapists
    • Prosthodontists
    • Psychiatrists
    • Psychologists
    • Social workers
    • Otolaryngologists

Exclusion Criteria:

  • patients who don't suffer from cleft lip and palate
  • other specialists who aren't involved in the CLP team

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
orthodontists
orthodontists with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
general dentists
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
oral and maxillofacial surgeons
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
plastic surgeons
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
cleft nurses
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
speech therapists
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
ENT specialists
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
psychiatrists
with more than 2 years of working experience
Other: Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
Social workers
with more than 2 years of working experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the presence or absence of a multidisciplinary treatment approach for CLP patients
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Actual)

January 15, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HanaAdelAdawyCU2021

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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