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CTRI Number  CTRI/2026/01/102074 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding how a infants tongue-tie might affect breastfeeding and to find their interrelationship 
Scientific Title of Study   Association Between Lingual Frenum Attachment and Breastfeeding Difficulties in Infants Using Clinical Assessment Tools: A Cross-Sectional Observational Study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1316-6380  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Pandey 
Designation  Medical Director, Consultant OB and GYN 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Dept of Ob & Gyn, Uttaranchal Hospital, a unit of Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone    
Fax    
Email  drpreetiuttaranchalhospital@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meru S 
Designation  Principal, Professor and Head 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 1 Department of Oral Medicine & Radiology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meru S 
Designation  Principal, Professor and Head 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 1 Department of Oral Medicine & Radiology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Source of Monetary or Material Support  
Uttaranchal Hospital, Majri Grant, Haridwar road, Dehradun 
 
Primary Sponsor  
Name  Uttaranchal Dental and Medical Research Institute 
Address  Majri Grant, Haridwar road, Dehradun 
Type of Sponsor  Other [Private Dental 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 Meru S  Uttaranchal Dental and Medical Research Istitute  Ward no 1, Ob and Gyn ward, Uttaranchal Hospital, a unit of Uttaranchal Dental and Medical Research Institute, Majri Grant, Haridwar road, Dehradun
Dehradun
UTTARANCHAL 
8126192404

drmeru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Uttaranchal Dental and Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  6.00 Month(s)
Gender  Both 
Details  1. Infants aged upto 6 months.
2. Breastfeeding infants with or without feeding challenges.
3. Lactating mothers willing to participate and provide informed consent
 
 
ExclusionCriteria 
Details  1. Infants with congenital oral or craniofacial anomalies unrelated to the lingual frenum.
2. Exclusively bottle-fed infants.
3. Infants with prior surgical correction of ankyloglossia
4. Infants diagnosed with cretinism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Bristol Tongue Assessment Tool (BTAT)
1. Tongue tip appearance-
a. Heart shaped- 0
b. Slight cleft/notched- 1
c. Rounded-2
2. Attachment to the lower gum ridge-
a. Attached at top of gum ridge- 0
b. Attached to inner aspect of gum- 1
c. Attached to floor of mouth- 2
3. The lift of the tongue is seen when the infant is awake and is viewed when the infant is crying.
a. Minimal tongue lift- 0
b. Edges only to mid-mouth- 1
c. Full tongue lift to mid-mouth- 2
4. Protrusion of the tongue.
a. Tip stays behind gum- 0
b. Tip over gum- 1
c. Tip can extend over lower lip- 2
 
observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   02/02/2026 
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="6"
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  

Introduction

Ankyloglossia, also known as tongue-tie, is a condition that impairs tongue movement due to a restrictive lingual frenulum. The presence of a tongue-tie (ankyloglossia) in an infant may lead to breastfeeding difficulties.1 The incidence of tongue-tie ranges from 3% to 16% worldwide and the presence of a tongue-tie in an infant may lead to breastfeeding difficulties. This wide range of prevalence is partly because of the lack of a single definition and the differences among investigators.2 Anterior ankyloglossia is classic ankyloglossia, where the frenulum attaches at or close to the tongue tip, limiting tongue mobility.  Diagnosis of posterior ankyloglossia remains a subject of controversy. Posterior ankyloglossia occurs when the frenulum attaches to the posterior aspect of the ventral surface of the tongue and restricts tongue mobility. Some also use the term to refer to the submucosal tethering of the tongue. Others consider posterior ankyloglossia normal frenulum attachment and attribute breastfeeding difficulties to other factors, like nipple anatomy, maternal milk production, and maternal experience.2 Maxillary lip frenulum tethering has also been reported to affect breastfeeding. Ingram et al. in 2015 developed the Bristol Tongue Assessment Tool (BTAT).3 The Bristol Tongue Assessment Tool provides an objective, clear and simple evaluation of the severity of the tongue-tie.4 Whilst the importance of breastfeeding is widely recognised, supporting it can be challenging. the Infant Breastfeeding Assessment Tool (the IBFAT) to assess and measure infant breastfeeding competence. It was designed for use by mothers, midwives and other health professionals.5

Frenotomy for ankyloglossia has increased nearly 10-fold over the past few decades despite insufficient evidence that the procedure improves breastfeeding outcomes. There is no universally accepted method for identifying patients who may benefit from the procedure.6 The objective of this observational study is to determine the association between classification of lingual frenum using BTAT and assess breastfeeding difficulties using IBFAT.

Null hypothesis:

There is no association between the different levels of lingual frenum attachment with experience of difficulty in breast feeding.

Aim and objectives:

The aim of the study is to assess the correlation between the level of lingual frenum attachment with difficulty in breast feeding in infants

The objectives of the study are-

1.     To assess the level of lingual frenum attachment in infants using the Bristol Tongue Assessment Tool (BTAT).

2.     To evaluate breastfeeding difficulties using the Infant Breastfeeding Assessment Tool (IBFAT).

3.     To determine the correlation between BTAT scores and IBFAT scores, identifying the impact of lingual frenum attachment on breastfeeding success.

Inclusion criteria:

1.     Infants aged 0–6 months.

2.     Breastfeeding infants with or without feeding challenges.

3.     Lactating mothers willing to participate and provide informed consent.

Exclusion Criteria:

1.     Infants with congenital oral or craniofacial anomalies unrelated to the lingual frenum.

2.     Exclusively bottle-fed infants.

3.     Infants with prior surgical correction of ankyloglossia.

1. Assessment of Lingual Frenum Attachment

  • Tool: Bristol Tongue Assessment Tool (BTAT)

1.     Tongue tip appearance-

a.      Heart shaped- 0

b.     Slight cleft/notched- 1

c.      Rounded-2

2.     Attachment to the lower gum ridge-

a.      Attached at top of gum ridge- 0

b.     Attached to inner aspect of gum- 1

c.      Attached to floor of mouth- 2

3.     The lift of the tongue is seen when the infant is awake and is viewed when the infant is crying.

a.      Minimal tongue lift- 0

b.     Edges only to mid-mouth- 1

c.      Full tongue lift to mid-mouth- 2

4.     Protrusion of the tongue.

a.      Tip stays behind gum- 0

b.     Tip over gum- 1

c.      Tip can extend over lower lip- 2

The scores for the four items are summed and can range from 0 to 8. Scores of 0–3 indicate more severe reduction of tongue function.

2. Breastfeeding Evaluation

  • Tool: Infant Breastfeeding Assessment Tool (IBFAT)

1.     Readiness to feed or arousability. The observer is asked to record whether,

a.       the baby started to feed readily without effort (score 3),

b.     needed mild stimulation to start to feed (score 2),

c.      needed more vigorous stimulation to rouse and start to feed (score 1) or

d.     if the baby could not be roused (score 0).

2.     Rooting. This is defined in the standard way as ’At the touch of the nipple to the baby’s cheek, the head turns towards the nipple, the mouth opens and baby attempts to fix the mouth on the nipple’. The observer then recorded whether the baby,

a.      when placed beside the breast, rooted effectively at once (score 3),

b.     needed some coaxing, prompting, or encouragement to root (score 2),

c.      rooted poorly, even with coaxing (score 1)

d.     did not try to root (score 0)

3.     Fixing. The observer recorded the length of time, from placing the baby at the breast, that it took for the baby to ’latch on’ and start to feed well.

a.      Did he or she start to feed at once (score 3),

b.     take 3 to 10 minutes (score 2),

c.      take over 10 minutes (score 1) or

d.     did not feed (score 0)

4.     Sucking pattern. The observer was asked to choose the phrase which best described the baby’s feeding pattern at the feed.

a.      This ranged from ’baby did not suck’ (score 0),

b.     through ’sucked poorly’ (i.e., weak sucking, some sucking efforts for short periods) (score 1),

c.      ’sucked fairly well’ (sucked off and on, but needed encouragement) (score 2), or

d.     ’sucked well on one or both breasts’ (score 3).

 

3. Data Collection

·        Maternal Input:

o   History of breastfeeding difficulties (e.g., nipple pain, poor latch).

o   Perceived breastfeeding satisfaction.

·        Clinical Examination:

o   BTAT performed during routine oral examination.

·        Questionnaire Administration:

o   IBFAT scores completed during a feeding session with assistance from clinicians.

4. Data Analysis

·        Descriptive statistics for demographic and clinical data.

·        Correlation analysis (Pearson or Spearman coefficient) to assess the relationship between BTAT and IBFAT scores.


 
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