跳至主要内容
临床试验/NCT06451276
NCT06451276尚未招募不适用

The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Alveolar Ridge, Nasal and Labial Growths in Children With Unilateral Cleft Lip and Palate

Al-Azhar University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
4
主要终点
Posterior ends of alveolar crest

研究概览

简要总结

The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate.

objectives: -

  1. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.
  2. Evaluation of the nasal symmetry.

详细描述

cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. Unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. Additionally, it predominantly affects males, with a male-to-female ratio of 2:1. Common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. Peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. Additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side.

Conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. However, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. Therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. The introduction of the presurgical Nasoalveolar molding (NAM) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . These interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
7 Days 至 12 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 1- 8 weeks.
  • Gender: male and female.
  • Patients with a unilateral cleft alveolus and lip.
  • No developmental syndromes or atypical cleft pathology in medical history.
  • No previous history of unilateral CLP correction.
  • Motivated parents toward the treatment.

排除标准

  • Patients with a bilateral cleft alveolus and lip
  • Syndromic patient
  • Uncooperative caregiver

结局指标

主要结局

Posterior ends of alveolar crest

时间窗: 3 months

width between the most posterior ends of the alveolar crest in the greater segment and lesser segment

Mid line of maxilla

时间窗: 3 months

Inc-Sagittal: - Perpendicular distance from Inc point (The intersection points between the labial frenum-incisive papilla point line and the alveolar crest of the premaxilla in the greater segment) to sagittal line (The perpendicular line to the PG-PL line)

Middle ends of alveolar crest

时间窗: 3 months

width between the middle parts of the cleft palate (The intersection points between the palatally extended buccal frenum sulcus line and the palatal gingival groove in the greater and lesser segment

Anterior ends of alveolar crest

时间窗: 3 months

The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)

Angulation of maxilla

时间窗: 3 months

Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line

次要结局

  • Alar base width(3 months)
  • Columella angle deviation.(3 months)
  • Columella length.(3 months)
  • Nostril height and width on the cleft side.(3 months)
  • Nostril height and width on the non-cleft side(3 months)
  • Nasal ridge deviation.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Farghly Abdelnaeem Ahmed

Doctor

Al-Azhar University

研究点 (4)

Loading locations...

相似试验