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

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Other: Questionnaire

• Registration Number: NCT04696237
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-01-15
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
psychiatrists	Questionnaire	with more than 2 years of working experience
speech therapists	Questionnaire	with more than 2 years of working experience
general dentists	Questionnaire	with more than 2 years of working experience
plastic surgeons	Questionnaire	with more than 2 years of working experience
oral and maxillofacial surgeons	Questionnaire	with more than 2 years of working experience
ENT specialists	Questionnaire	with more than 2 years of working experience
orthodontists	Questionnaire	orthodontists with more than 2 years of working experience
cleft nurses	Questionnaire	with more than 2 years of working experience

Primary Outcome Measures

Name	Time	Method
the presence or absence of a multidisciplinary treatment approach for CLP patients	3 months

Trial Locations

Locations (1)

CairoU; 🇪🇬 Cairo, Egypt