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CTRI Number  CTRI/2025/09/094954 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of tongue tie in infants  
Scientific Title of Study   Prevalence of tongue tie with feeding difficulties in Navi Mumbai Region – A cross sectional 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  Dr J JASMIN WINNIER  
Designation  ASSOCIATE PROFESSOR  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu   
 
Details of Contact Person
Scientific Query
 
Name  Dr Aastha Sharma  
Designation  Post Graduate Student  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  7208712815  
Fax    
Email  aastha2409@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aastha Sharma  
Designation  Post Graduate Student  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  7208712815  
Fax    
Email  aastha2409@yahoo.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706  
 
Primary Sponsor  
Name  Dept of Pediatric and Preventive Dentistry  
Address  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706  
Type of Sponsor  Private medical college 
 
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 J Jasmin Winnier   D Y Patil University School of Medicine   Dept of Pediatrics , Dr D Y Patil Deemed to be University, School Of Medicine , Sector 7, Highway Road, , Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA 
09773284371

jasmin.winnier@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q381||Ankyloglossia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  1.00 Year(s)
Gender  Both 
Details  Normal healthy children
Age range 0-1 year
Children born/residing in Navi Mumbai region
Informed consent form signed by parents/guardians
 
 
ExclusionCriteria 
Details  Informed consent not given by the parent
Children with any systemic diseases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of tongue-tie in 0–1-year-old.
Association of tongue tie with feeding difficulties among breastfeeding mothers .
 
To determine the prevalence of tongue-tie in 0–1-year-old.
Association of tongue tie with feeding difficulties among breastfeeding mothers .
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="113"
Sample Size from India="113" 
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   N/A 
Date of First Enrollment (India)   30/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The study will be conducted in Outpatient Department of Pediatrics  at D.Y. Patil Hospital, Nerul, Navi Mumbai   . A informed consent will be taken from parents before assessment.

Examination will be carried out in good lighting . Before beginning, hands will be washed thoroughly and clean gloves will be worn to maintain hygiene and minimize any risk of infection.

The infant should be positioned securely, either on the caregiver’s lap or in a supine position and will ensure that the infant is calm and at ease to facilitate a thorough and accurate evaluation. Using a gloved finger ; infant’s tongue will be gently lifted to visualize the frenulum located underneath. Structure and attachment of the frenulum will be observed and any potential abnormalities such as tightness, restrictions will be noted .Additionally ; assessment of  tongue’s range of motion by observing its movements when stimulated or gently manipulated.

The functional assessment includes observing the infant during feeding . Feeding difficulties, such as an inability to maintain a latch, frequent interruptions, or frustration during feeding, will  be noted.The sucking reflex will be assessed by placing a gloved finger in the infant’s mouth to determine the tongue’s ability to form a proper seal.

Assessment tool

The Coryllos Classification of Tongue-Tie was introduced by Dr. Evelyn Coryllos and colleagues in the 2004. This system categorizes ankyloglossia (tongue-tie) into four types based on the anatomical location and severity of the frenulum’s attachment to the tongue. It is commonly used to evaluate the impact of tongue-tie on feeding, speech, and oral functions

The Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF) was developed by Dr. Alison Hazelbaker and published in 1993. It is designed to evaluate both the functional movement and anatomical characteristics of the lingual frenulum in infants. This tool is widely used to diagnose tongue-tie and assess its impact on breastfeeding. It uses a scoring system to classify tongues into one of three categories: functionally impaired, acceptable or perfect.

The LATCH score, developed by Jensen, Wallace, and Kelsay in 1994, is a breastfeeding assessment tool that evaluates five key components: Latch, Audible swallowing, Type of nipple, Comfort, and Hold/positioning. Each is scored from 0 to 2, with a maximum score of 10 indicating effective breastfeeding. It helps healthcare providers identify challenges like poor latch or discomfort and guide interventions to improve breastfeeding outcomes

 
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