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临床试验/CTRI/2023/11/060236
CTRI/2023/11/060236招募中4 期

Comparative Evaluation of Speech Articulation Outcomes usingFrenectomy with Linear Closure versus Z Plasty for Management ofAnkyloglossia in Paediatric Subjects A Prospective RandomizedControl Study.

MGM Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月12日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
30
试验地点
1
主要终点
To evaluate and compare Speech Articulation Outcomes following Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects

研究概览

简要总结

Ankyloglossia, commonly known as tongue-tie, is a congenital anomaly characterized by an abnormally short lingual frenulum. The phenotype varies from absence of clinical significance to rare complete ankyloglossia where the ventral part of the tongue is fused to the floor of the mouth. Ankyloglossia is anatomically characterized by an abnormally short, thick, or tight tongue frenulum and limits tongue movement, which may contribute to multiple dysfunctions, including difficulties in breastfeeding, swallowing, and speech articulation. Tongue-tie has been suggested to cause breast-feeding difficulties (sore nipples, poor infant weight gain, early weaning), speech disorders (impaired articulation), problems with deglutition and dentition, oral-motor dysfunction and social issues related to the limited function of the tongue. Tongue-tie can be considered a relatively common anomaly with a prevalence of approximately 4—5%. For unknown reasons the abnormality seems to be more common in males with male to female ratio of 2.3—2.7:1.0 Despite the fact that breastfeeding problems are thought to be the

most common therapeutic indication among newborn infants with ankyloglossia, defects in articulation are the main complaints of preschoolers and older children.

Recognition of the negative role of a short lingual frenulum led specialists to develop sophisticated protocols to investigate infants and children with short lingual frenuluae, but the association between a short lingual frenulum and OSAS is currently unrecognized. The most common method to correct ankyloglossia is by the surgical excision of aberrant frenal attachments.

Although a lot of literature is available on the methods and techniques to correct ankyloglossia , scant literature is available in which postoperative speech has been assessed with the use of different techniques. Thus, the present study aims to evaluate and compare the speech outcomes with the use of 2 different techniques of closure. The study also aims to evaluate the improvement in the anatomy of the airway as a direct result of frenectomy , if any.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
3.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Patients within the age group 03 to 11 years.

排除标准

  • Any congenital abnormality in the craniofacial region.
  • Children with abnormal mental development.
  • Cleft abnormalities affecting speech.
  • Maxillofacial deformities affecting speech.

结局指标

主要结局

To evaluate and compare Speech Articulation Outcomes following Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects

时间窗: Preoperative speech evaluation. | Postoperative speech evaluation at 3 months.

次要结局

  • To evaluate and compare Volume of the Upper Airway following(Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects.)

研究者

申办方类型
Other [Private Dental College and Hospital]

研究点 (1)

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