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IRCT20180828040897N1 IRCT 2018-12-21 Mashhad University of Medical Sciences The effect of immediate and delayed addition of nasal stent to nasoalveolar molding plate among patients with unilateral cleft lip and palate Comparative evaluation of immediate and delayed addition of nasal stent to nasoalveolar molding plate on nostrils shape and cleft width among patients with unilateral cleft lip and palate 2018-11-22 anticipated 20 Complete https://irct.ir/trial/33678 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization based on blocking method, Blinding description: Patients are unaware to what intervention or control group they will be assigned. N/A Condition 1: Cleft palate. Condition 2: cleft lip. Intervention 1: Control group: 10 patients with unilateral cleft of lip and palate are included. First, all patients are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque is performed when the width of the cleft is 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. The treatment continues for 2 months after insertion of the stent in each group, and ultimately the patients will be referred to the radiology clinic for a final scan of the face with the proface software. Intervention 2: Intervention group: 10 patients with unilateral cleft of lip and palate are included. First, all infants are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque in the initial phase of the treatment occurs when the cleft width is greater than 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. After 2 months of insertion of the stent, the infants will be referred to the radiology clinic for a final scan of the face with the proface software. Yes - There is a plan to make this available What will be shared: A portion of the data, such as data on the main outcome or like that can be shared. When: Starting the access period 6 months after printing results To whom: own data will only be available to researchers working in academic and academic institutions Conditions: You have to completely control the data and get the credentials from the author. Where to obtain: Abdollah Jamalinasab. Email: abdollah jamalinasab@yahoo.com How to obtain: The requestor can contact by e-mail. Information is available as soon as possible Comments:
public Arezo Jahanbin
Mashhad Dental School, Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3883 2301 abdollahjamalinasab@yahoo.com Mashhad University of Medical Sciences scientific Arezo Jahanbin
Mashhad Dental School, Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3883 2301 abdollahjamalinasab@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Age under one month Alveolar width greater than 6 mm Parent's cooperation Informed consent 1 day 30 days Both Syndromic disease (patients) Q35 Q36 Cleft palate Cleft lip Treatment - Devices Treatment - Devices Control group: 10 patients with unilateral cleft of lip and palate are included. First, all patients are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque is performed when the width of the cleft is 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. The treatment continues for 2 months after insertion of the stent in each group, and ultimately the patients will be referred to the radiology clinic for a final scan of the face with the proface software. Intervention group: 10 patients with unilateral cleft of lip and palate are included. First, all infants are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque in the initial phase of the treatment occurs when the cleft width is greater than 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. After 2 months of insertion of the stent, the infants will be referred to the radiology clinic for a final scan of the face with the proface software. Columellar deviation angle: The intercalary angle that passes from the Clomarlar with the horizontal line in the subjective mental view of the radiograph. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). Nostril width: The greatest distance between the clommler and the alar of nose in each side. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). Nostril hight: the distance between the anteriormost point of the nasal cavity and the posterior part of the nose. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). Inter comisural distance: the distance between the two corners of the lip. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). Soft tissue cleft width: Maximum distance from the two edges of the cleft lip. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). The nasal area is on the left and right side of the line from Nasion to Subnasal. Timepoint: The beginning and the end of the treatment. Method of measurement: Using proface software (picture derived from software). Clinical width of the gap. Timepoint: Weekly until the end of the study. Method of measurement: Use a caliper with a precision of 1 mm for. Width of the gap. Timepoint: Monthly until the end of the study. Method of measurement: Based on models scanned with Cone beam computed tomography. Mashhad University of Medical Sciences Approved 2018-10-28 Ethics Committee of the Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Vakil Abad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)