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A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive lip taping | Experimental | Will receive passive baby feeding plate and conventional steri strip |
|
| Custom-made tape | Experimental | will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lip taping | Device | Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of maxillary arch dimension change | To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Linear measurement change | The linear measurements of arch dimensions in millimeter before and after treatment with both methods of lip taping in both experimental groups Linear measurements for maxillary arch assessments in millimeters:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mushriq Abid, PhD | Contact | 7718800706 | 00964 | mushriq.abid@codental.uobaghdad.edu.iq |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry | Recruiting | Baghdad | Al-Rusaffa | 01110 | Iraq |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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|
| T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] |
| Assessment of Angular measurement change | The angular measurements of arch dimensions in degrees before and after treatment with both methods of lip taping in both experimental groups. Angular measurements for maxillary arch assessments in degrees: Anterior arch curvature angle (AIA') | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] |
| Assessment of Parents Perception and experience | The perception and experience of parents of children with cleft lip and palate concerning the use presurgical infant orthopedics using a questionnaire-based cross-sectional survey. The assessment of mothers' perception and experience regarding PSIO will be executed using 15 validated preformed questions. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |