Clinical trial NCT04696237: National Treatment Approach Versus Standardized Treatment Protocol to Manage Patients With Cleft Lip and Palate: a Cross Sectional Study
Official title: National Treatment Approach Versus Standardized Treatment Protocol to Manage Patients With Cleft Lip and Palate: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: the presence or absence of a multidisciplinary treatment approach for CLP patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: CairoU
Study officials:
References: