| CTRI Number |
CTRI/2026/01/100663 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Upper Lip Tie Affects Breastfeeding in Babies: An assessment using a new tool |
|
Scientific Title of Study
|
Determination of correlation of upper lip tie and breast-feeding difficulty in infants using hop-roc assessment: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 M S Saravana Kumar |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Room No 6 Main Block Second Floor Sri Venkateswara Dental College and Hospital Off Old Mahabalipuram Road Near Navalur Thalambur Chennai 6000130 Tamil Nadu India
Chennai
TAMIL NADU
6000130
India |
| Phone |
9444522345 |
| Fax |
|
| Email |
mssaravanapedo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S Saravana Kumar |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Room No 6 Main Block Second Floor Sri Venkateswara Dental College and Hospital Off Old Mahabalipuram Road Near Navalur Thalambur Chennai 6000130 Tamil Nadu India
Chennai
TAMIL NADU
6000130
India |
| Phone |
9444522345 |
| Fax |
|
| Email |
mssaravanapedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Saravana Kumar |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Room No 6 Main Block Second Floor Sri Venkateswara Dental College and Hospital Off Old Mahabalipuram Road Near Navalur Thalambur Chennai 6000130 Tamil Nadu India
Chennai
TAMIL NADU
6000130
India |
| Phone |
9444522345 |
| Fax |
|
| Email |
mssaravanapedo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr M S SaravanaKumar |
| Address |
Room No 6 Main Block Second Floor Sri Venkateswara Dental College and Hospital Off Old Mahabalipuram Road Near Navalur Thalambur Chennai 6000130 Tamil Nadu India |
| Type of Sponsor |
Other [Self] |
|
|
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 MS Saravana Kumar |
Athirran Multispeciality clinic |
No.2/609, post office road,OMR, Thoraipakkam, Chennai
Chennai
TAMIL NADU |
09444522345
mssaravanapedo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AND SCIENTIFIC REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q380||Congenital malformations of lips,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Observational study |
| Intervention |
Nil |
Observational study |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
Infants 0 to18 months of age
Breast-feeding mothers of infants 0 to 18 months
Healthy infant and Breast-feeding mother
Parents of the infants who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Infants admitted to neonatal intensive care unit
History of frenectomy
Infants with cleft lip and palate
Infants diagnosed with craniofacial anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The infant’s upper lip was elevated and photographed with a standard ruler using a high-definition camera. Measurements were calibrated with Digimizer software. The superior labial frenum was assessed using the Hopkin–Rochester (HOP-ROC) 3-point scale. Breast-feeding experience was evaluated using the Infant Breast-Feeding Assessment Tool (IBFAT).
|
All assessments will be conducted at a single time point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The infant’s upper lip was elevated & photographed with a standard ruler using a high-definition camera. Measurements were calibrated with Digimizer software. The superior labial frenum was assessed using the Hopkin–Rochester (HOP-ROC) 3-point scale. Breast-feeding experience was evaluated using the Infant Breast-Feeding Assessment Tool (IBFAT).
|
All assessments will be conducted at a single time point |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
27/03/2026 |
| 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="2"
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
|
Thirty three infants will be examined in pediatric hospitals in Chennai. Infants weight, age and demographic data will be collected from infant’s medical record. A standardised protocol will be followed to capture images of the superior labial frenulum of the infants. Each infant’s upper lip was elevated and retracted to the level of alveolar sulcus. A standard ruler will be placed into the image frame and multiple pictures of infant’s superior labial frenum (SLF) will be obtained. Digimiser software will be used to calibrate the measurement scale for each photograph. Assessment of the superior labial frenum is done by Hopkin-Rochester [HOP-ROC].
Three point scale including the parameters such as length of frenulum on stretch, length of alveolar edge to gingival attachment length and free - lip to total lip length ratio. Based on the scores obtained according to the parameters, infants will be grouped into three risk categories: Low (0), Medium (1,2), High (3).
Infant Breast- Feeding Assessment Tool (IBFAT) questionnaire will be used to evaluate the breast feeding experience of the mothers of the infants. IBFAT is a validated four item questionnaire describing infant’s breast feeding on scale from 0-12 points, each answer provides a score (0-3) proportional to the infant’s efficacy in breast feeding. Score less than or equal to 8 reveal difficult breast feeding.
Correlation between the risk categories and breast feeding scores will be analysed. |