Cleft Lip and PalateNCT04696237
National Treatment Approach Versus Standardized Treatment Protocol to Manage Patients With Cleft Lip and Palate: a Cross Sectional Study
An observational study of Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Questionnaire
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 30 Oct 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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
Who may be able to join
- • 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
Show all 15Show fewer
- Plastic surgeons
- Orthodontists
- Nurses
- Speech therapists
- Prosthodontists
- Psychiatrists
- Psychologists
- Social workers
- Otolaryngologists
Who cannot join
- patients who don't suffer from cleft lip and palate
- other specialists who aren't involved in the CLP team
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cleft Lip and Palate
- Being tested
- Questionnaire
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
| Study group | Role | What they receive |
|---|---|---|
| orthodontists | orthodontists with more than 2 years of working experience Receives: Other: Questionnaire | |
| general dentists | with more than 2 years of working experience Receives: Other: Questionnaire | |
| oral and maxillofacial surgeons | with more than 2 years of working experience Receives: Other: Questionnaire | |
| plastic surgeons | with more than 2 years of working experience Receives: Other: Questionnaire | |
| cleft nurses | with more than 2 years of working experience Receives: Other: Questionnaire | |
| speech therapists | with more than 2 years of working experience Receives: Other: Questionnaire | |
| ENT specialists | with more than 2 years of working experience Receives: Other: Questionnaire | |
| psychiatrists | with more than 2 years of working experience Receives: Other: Questionnaire | |
| Social workers | with more than 2 years of working experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence or absence of a multidisciplinary treatment approach for CLP patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hana Adel Adawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696237
- Sponsor's protocol ID
- HanaAdelAdawyCU2021
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Treatment Approach Versus Standardized Treatment Protocol to Manage Patients With Cleft Lip and Palate: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04696237
- Acronym / sponsor ID
- HanaAdelAdawyCU2021
- Conditions
- Cleft Lip and Palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| orthodontists | – | Other: Questionnaireorthodontists with more than 2 years of working experience |
| general dentists | – | Other: Questionnairewith more than 2 years of working experience |
| oral and maxillofacial surgeons | – | Other: Questionnairewith more than 2 years of working experience |
| plastic surgeons | – | Other: Questionnairewith more than 2 years of working experience |
| cleft nurses | – | Other: Questionnairewith more than 2 years of working experience |
| speech therapists | – | Other: Questionnairewith more than 2 years of working experience |
| ENT specialists | – | Other: Questionnairewith more than 2 years of working experience |
| psychiatrists | – | Other: Questionnairewith more than 2 years of working experience |
| Social workers | – | –with more than 2 years of working experience |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (15 listed)
- • 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)
Key exclusion criteria (2 listed)
- patients who don't suffer from cleft lip and palate
- other specialists who aren't involved in the CLP team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairea questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed | Other | ENT specialists, cleft nurses, general dentists, oral and maxillofacial surgeons, orthodontists, plastic surgeons, psychiatrists, speech therapists |
Primary outcome
the presence or absence of a multidisciplinary treatment approach for CLP patients
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence or absence of a multidisciplinary treatment approach for CLP patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.