FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100637 [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   A Study Observing Breathing Problems During Sleep in Children with Tongue-Tie  
Scientific Title of Study   Determinants of sleep-disordered breathing in tongue-tied children: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 Saravanakumar 
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
600130
India 
Phone  9444522345  
Fax    
Email  mssaravanapedo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.R.VIJAYALAKSHMI 
Designation  Postgraduate Student 
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
600130
India 
Phone  9710205758  
Fax    
Email  rviji23pedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M S Saravanakumar 
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
600130
India 
Phone  9444522345  
Fax    
Email  mssaravanapedo@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
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  
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 M S Saravanakumar  Sri Venkateswara Dental College and Hospital  Room No 2 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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q381||Ankyloglossia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Healthy children between 6 and 18 years of age with a diagnosis of tongue-tie were included in the study. Assessment of tongue-tie was performed using the Kotlow assessment, carried out with maximum mouth opening and the tip of the tongue touching the palatal papilla. The free tongue length was measured to the nearest millimetre and graded as follows: normal range of free tongue, greater than 16 mm; Class I, mild ankyloglossia, 12–16 mm; Class II, moderate ankyloglossia, 8–11 mm; Class III, severe ankyloglossia, 3–7 mm; and Class IV, complete ankyloglossia, less than 3 mm. The Quick Tongue-Tie Assessment Tool was used for the measurement of Kotlow’s free tongue length.
Parents of the children who consented to participate in this study.
This study will be conducted in the department of Pediatric and Preventive Dentistry of Sri Venkateswara dental college & hospital and Schools in Chennai.Kotlow tongue tie class II, class III and class IV are included in tongue tie group.
Children with normal range of free tongue of more than 16mm are included in control group. 
 
ExclusionCriteria 
Details  Children with history of frenectomy, Children undergoing orthodontic treatment, maxillary expansion, Children underwent maxillofacial surgery, Missing or ectopic eruption of canines or first molars,Functional trismus,Syndromic / maxillofacial deformity / developmental anomalies.
and Children with special health care needs
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tongue mobility was measured using TRMR with tongue tip movements and assessed with the Quick Tongue Tie Tool. Intercanine, intermolar distances and molar relationship were measured using an intraoral scanner. Nasal breathing was tested with lips sealed with micropore tape for up to 180 seconds. Mallampati score was assessed clinically. Sleep was evaluated using the Children Sleep Habits Questionnaire.  All assessments are done at a single point 
 
Secondary Outcome  
Outcome  TimePoints 
Tongue mobility was measured using TRMR with tongue tip movements & assessed with the Quick Tongue Tie Tool. Intercanine, intermolar distances & molar relationship were measured using an intraoral scanner. Nasal breathing was tested with lips sealed with micropore tape for up to 180 seconds. Mallampati score was assessed clinically. Sleep was evaluated using the Children Sleep Habits Questionnaire.  All assessments are done at a single time 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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  

Children with age group between 6 to 18 years will be screened for inclusion and exclusion criteria. Participants will be recruited in study on rendering informed consent. This study will be conducted in the department of Pediatric and Preventive Dentistry of Sri Venkateswara dental college & hospital and Schools in Chennai. Assessment of tongue-tie by Kotlow assessment is by using quick tongue tie assessment tool. Measurements of the free tongue is carried out with maximum mouth opening and tip of the tongue touching the palatal papilla with results expressed in and read to the nearest millimeter and graded accordingly.

Clinical assessment tool measurements assessing functional and intraoral soft tissue determinants are recorded during a routine dental examination.

Depending on the selection criteria as mentioned above the children will be categorized into two groups:

Group 1: Tongue tied (test)

Group 2: Non tongue tied (control)

 The study involved six main components in control and test group:

(i) Functional measurement of tongue mobility,

(ii) Inter canine measurement of the maxillary arches using intraoral scanner and

(iii) Intermolar measurement of the maxillary arches using intraoral scanner,

(iv) Assessment of nasal breathing,

(v) Mallampati score

(vi) Angle molar classification

Measurements of tongue mobility using TRMR [Tongue Range of Motion Ratio] are performed with TIP [tongue tip extended towards the incisive papilla] and LPS [lingual-palatal suction] functional movements. Assessment of tongue mobility is by using quick tongue tie assessment tool. Intercanine distance is assessed by intraoral scanner by measuring the distance between Maxillary Canine tips.Intermolar distance is also assessed by intraoral scanner by measuring the distance between Maxillary first molar mesiobuccal cusp tips.For Nasal breathing test assessment, Lips and mouth of the subject were sealed completely with gentle MicroPore paper tape. A timer was used to assess how long the subject could comfortably breathe through the nose for up to 180 seconds with the lips and mouth taped. Subjects were deemed to pass the test if they could successfully breathe through the nose for three minutes.For Mallampati score assessment, the patient is seated in the upright position and opens their mouth while maximally protruding their tongue.Intraoral scanner is used for assessing the molar relationship (Anteroposterior arch relationship) on the basis of Angle’s definition.Children sleep habit questionnaire is used to assess sleep of the chidren. 

 
Close