Surgically Repaired Unilateral Cleft Lip and PalateNCT03219021
Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate
An observational study of Surgically Repaired Unilateral Cleft Lip and Palate, run by Menna Allah Mohammed Awad.
Trial summary
The aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgically Repaired Unilateral Cleft Lip and Palate
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2017
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with surgically repaired unilateral cleft lip and palate
Who may be able to join
- Children with cleft lip and palate from the age group: 8-10 years.
- Unilateral Cleft lip and palate children.
- Children who had been operated with lip and palate closure
Who cannot join
- Cleft lip and palate patients with systemic diseases, autoimmune conditions, syndromes.
- Children with any arch expansion or orthodontic procedure or previous history of orthodontic treatment.
- The presence of early loss of deciduous molars.
- Parents refusing participation in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate: A Cross Sectional Study
The aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate.
Read the detailed description
Measurements of arch widths will be performed in the maxillary and mandibular arches after performing a study cast. Alginate impression of the upper and lower arch of all participating children will be performed and poured immediately to prevent dimensional changes.
The inter-deciduous canine, inter-permanent molar, and the distances between the first and second deciduous molars will be measured using a digital caliper directly on dental casts by a single examiner.
Distance measurements will be obtained between cusp tips of canines, cusp tips of first deciduous molars, mesiobuccal cusp tips of second deciduous molars, and mesiobuccal cusp tips of first permanent molars. Estimated cusp tips will be used in cases of wear facets.
Rationale:
Children with cleft lip and/or palate suffer from problems in growth of the jaws, particularly the maxilla (upper jaw), as a result of surgical repairs of the cleft lip and palate. It is important to know the arch dimensions of them to enable the identification of specific surgical alterations related to maxillofacial growth concerning the common treatment protocol for patients with cleft lip and palate.
Benefits to the practitioner:
-Increase the awareness of pediatric dentists about changes of arch dimensions of surgically repaired cleft lip and palate patients in Egypt.
Benefits to the patient:
- Inform parents about any disturbances that might be associated with Cleft lip and Palate.
- Guide them to the orthodontic care if needed.
Benefits to the community:
- Provide the Egyptian community with data concerning patients with cleft lip and palate.
- Increase awareness of problems related to Cleft Lip and Palate.
- Keywords
- Cleft lip and Palate, unilateral cleft lip and palate, surgically repaired cleft lip and palate, arch dimensions, arch discrepancies, dental arch dimensions, arch parameter, arch circumference, intercanine width, first deciduous molar width, second deciduous molar width, permanent first molar width
- Medical subject headings
- Cleft Lip
What is being measured
The primary outcome is the main question the study is designed to answer.
arch dimensions measures
Assessment of arch dimensions among children with surgically repaired unilateral cleft lip and palate in mm using digital caliper
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgically Repaired Unilateral Cleft Lip and PalateStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menna Allah Mohammed Awad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menna Allah Mohammed Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219021
- Sponsor's protocol ID
- CEBD-2017-7-170
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03219021
- Acronym / sponsor ID
- CEBD-2017-7-170
- Keywords
- Cleft lip and Palate, unilateral cleft lip and palate, surgically repaired cleft lip and palate, arch dimensions, arch discrepancies, dental arch dimensions, arch parameter, arch circumference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 233 participants (estimated)
- Lead sponsor
- Menna Allah Mohammed AwadUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 17 Jul 2017 (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 aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate.
Detailed description
Measurements of arch widths will be performed in the maxillary and mandibular arches after performing a study cast. Alginate impression of the upper and lower arch of all participating children will be performed and poured immediately to prevent dimensional changes.
The inter-deciduous canine, inter-permanent molar, and the distances between the first and second deciduous molars will be measured using a digital caliper directly on dental casts by a single examiner.
Distance measurements will be obtained between cusp tips of canines, cusp tips of first deciduous molars, mesiobuccal cusp tips of second deciduous molars, and mesiobuccal cusp tips of first permanent molars. Estimated cusp tips will be used in cases of wear facets.
Rationale:
Children with cleft lip and/or palate suffer from problems in growth of the jaws, particularly the maxilla (upper jaw), as a result of surgical repairs of the cleft lip and palate. It is important to know the arch dimensions of them to enable the identification of specific surgical alterations related to maxillofacial growth concerning the common treatment protocol for patients with cleft lip and palate.
Benefits to the practitioner:
-Increase the awareness of pediatric dentists about changes of arch dimensions of surgically repaired cleft lip and palate patients in Egypt.
Benefits to the patient:
- Inform parents about any disturbances that might be associated with Cleft lip and Palate.
- Guide them to the orthodontic care if needed.
Benefits to the community:
- Provide the Egyptian community with data concerning patients with cleft lip and palate.
- Increase awareness of problems related to Cleft Lip and Palate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with surgically repaired unilateral cleft lip and palate
Key inclusion criteria (3 listed)
- Children with cleft lip and palate from the age group: 8-10 years.
- Unilateral Cleft lip and palate children.
- Children who had been operated with lip and palate closure
Key exclusion criteria (4 listed)
- Cleft lip and palate patients with systemic diseases, autoimmune conditions, syndromes.
- Children with any arch expansion or orthodontic procedure or previous history of orthodontic treatment.
- The presence of early loss of deciduous molars.
- Parents refusing participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
arch dimensions measures
Time frame: Day 1
Assessment of arch dimensions among children with surgically repaired unilateral cleft lip and palate in mm using digital caliper
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgically Repaired Unilateral Cleft Lip and Palate, run by Menna Allah Mohammed Awad.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menna Allah Mohammed Awad, Master (+201146629499, amenna36@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arch dimensions measures (time frame: Day 1). 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 19 Jul 2017.