| 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
|
|
|
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
|
|
|
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 |