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CTRI Number  CTRI/2023/11/060236 [Registered on: 24/11/2023] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare effects of two different surgery techniques on speech in children with tongue tie 
Scientific Title of Study   Comparative Evaluation of Speech Articulation Outcomes using Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric Subjects A Prospective Randomized Control Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varad Rajendra Saptarshi 
Designation  Post Graduate Resident 
Affiliation  MGM Dental College & Hospital Navi Mumbai 
Address  MGM Dental College & Hospital Kamothe 4th Floor, Department of Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 & 19), Kamothe, Navi Mumbai, 410209.

Raigarh
MAHARASHTRA
410209
India 
Phone  9860203496  
Fax    
Email  drvaradsaptarshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Adil Gandevivala 
Designation  Associate Professor 
Affiliation  MGM Dental College & Hospital Navi Mumbai 
Address  MGM Dental College & Hospital Kamothe 4th Floor, Department of Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 & 19), Kamothe, Navi Mumbai, 410209.

Raigarh
MAHARASHTRA
410209
India 
Phone  9096815606  
Fax    
Email  dr.adilg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Adil Gandevivala 
Designation  Associate Professor 
Affiliation  MGM Dental College & Hospital Navi Mumbai 
Address  MGM Dental College & Hospital Kamothe 4th Floor, Department of Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 & 19), Kamothe, Navi Mumbai, 410209.

Raigarh
MAHARASHTRA
410209
India 
Phone  9096815606  
Fax    
Email  dr.adilg@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital 
 
Primary Sponsor  
Name  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital Kamothe 4th Floor Department of Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and 19 Kamothe Navi Mumbai 410209 
Type of Sponsor  Other [Private Dental College and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varad Rajendra Saptarshi  MGM DENTAL COLLEGE AND HOSPITAL  MGM Dental College & Hospital Kamothe 4th Floor, Department of Oral & Maxillofacial Surgery, Plot No. 1 & 2, Sector - 01(Old 18 & 19), Kamothe, Navi Mumbai, 410209.
Raigarh
MAHARASHTRA 
9860203496

drvaradsaptarshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGM Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Q381||Ankyloglossia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Linear Closure  Surgical release of Lingual frenum followed by closure with linear technique using resorbable suture 
Intervention  Z plasty Closure  Surgical release of Lingual frenum followed by closure with Z plasty technique using resorbable suture 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Patients within the age group 03 to 11 years. 
 
ExclusionCriteria 
Details  1. Any congenital abnormality in the craniofacial region.
2. Children with abnormal mental development.
3. Cleft abnormalities affecting speech.
4. Maxillofacial deformities affecting speech. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
To evaluate and compare Volume of the Upper Airway following
Frenectomy with Linear Closure versus Z Plasty for Management of Ankyloglossia in Paediatric subjects. 
Preoperative radiographic evaluation.
Postoperative radiographic evaluation at 3 months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 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.
 
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