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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696237
• Other study ID #: HanaAdelAdawyCU2021
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Other:
• Questionnaire
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed

Locations

Country	Name	City	State
Egypt	CairoU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the presence or absence of a multidisciplinary treatment approach for CLP patients		3 months