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Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum formed aligners group | Experimental | This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks |
|
| control group | No Intervention | This group will not receive any treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum formed aligners | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parents' satisfaction | It will be measured by questionnaire | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Nasal morphology( Height, width, angulation of columella | It will be measured in mm by Standardized Digital photographs | 3 months |
| Changes in Interlabial gab | It will be measured in mm by Standardized Digital photographs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khadega Ali Al Khateeb, Master | Contact | 00201100739869 | khadejaalkhateeb@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Abdu Abdelsayed, professor | Cairo University | Study Director |
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| 3 months |
| Changes in Maxillary arch dimension | It will be measured in mm by Digital models | 3 months |
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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