National Treatment Approach Versus Standardized Treatment... | NCT04696237

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

NCT04696237

Sponsor

Cairo University

Status

Completed

Last Update Posted

Nov 7, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Cleft Lip and Palate

Interventions

Questionnaire

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Oct 30, 2021Actual

First Submitted Date

Jan 4, 2021

First Submission Date that Met QC Criteria

Jan 4, 2021

First Posted Date

Jan 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2023

Last Update Posted Date

Nov 7, 2023Actual

Description Module

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

To identify if the healthcare providers in Egypt work in cleft centers or teams
To assess if the healthcare providers are aware of the interdisciplinary team-based treatment approach that should be followed for CLP patients' management.
To provide data about the cleft lip and palate management protocols that are being followed in Egypt.
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.
Identify the presence or absence of cleft centers in our country.
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.
Reporting the patients/parents' experiences throughout their treatment journey.
Highlight the obstacles that could be faced by the health care providers as well as the patients along the treatment journey.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed	ENT specialists cleft nurses

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided