A study to compare effects of two different surgery techniques on speech in children with tongue tie

Phase 4

Recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: Q381||Ankyloglossia,

Registration Number: CTRI/2023/11/060236

Lead Sponsor: MGM Dental College and Hospital

Brief Summary: 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 4â€”5%. For unknown reasons the abnormality seems to be more common in males with male to female ratio of 2.3â€”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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients within the age group 03 to 11 years.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare Speech Articulation Outcomes following Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects	Preoperative speech evaluation. \| Postoperative speech evaluation at 3 months.

Secondary Outcome Measures

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

Trial Locations

Locations (1): MGM DENTAL COLLEGE AND HOSPITAL
🇮🇳
Raigarh, MAHARASHTRA, India
MGM DENTAL COLLEGE AND HOSPITAL
🇮🇳Raigarh, MAHARASHTRA, India
Dr Varad Rajendra Saptarshi
Principal investigator
9860203496
drvaradsaptarshi@gmail.com