Trials / Unknown
UnknownNCT03011489
Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- Cairo University · Academic / Other
- Sex
- All
- Age
- 1 Week – 3 Months
- Healthy volunteers
- Accepted
Summary
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
Detailed description
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vacuum formed aligners | Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-06-01
- Completion
- 2017-12-01
- First posted
- 2017-01-05
- Last updated
- 2017-04-25
Source: ClinicalTrials.gov record NCT03011489. Inclusion in this directory is not an endorsement.