NCT04696237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

January 4, 2021

Last Update Submit

November 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • the presence or absence of a multidisciplinary treatment approach for CLP patients

    3 months

Study Arms (9)

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

with more than 2 years of working experience

Other: Questionnaire

psychiatrists

with more than 2 years of working experience

Other: Questionnaire

Social workers

with more than 2 years of working experience

Interventions

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

ENT specialistscleft nursesgeneral dentistsoral and maxillofacial surgeonsorthodontistsplastic surgeonspsychiatristsspeech therapists

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CairoU

Cairo, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in the Department of Orthodontics

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

January 15, 2021

Primary Completion

June 30, 2021

Study Completion

October 30, 2021

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations