| 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
|
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Scientific Title of Study
|
Determinants of sleep-disordered breathing in tongue-tied children:a cross-sectional study |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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] |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AND SCIENTIFIC REVIEW BOARD |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q381||Ankyloglossia, |
|
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Intervention / Comparator Agent
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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
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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 |
|
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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" |
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |