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CTRI Number  CTRI/2018/12/016759 [Registered on: 21/12/2018] Trial Registered Prospectively
Last Modified On: 12/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of sleep disturbances and dental malalignments in six to twelve year old children 
Scientific Title of Study   ASSESSMENT OF THE ASSOCIATION OF SLEEP DISORDERED BREATHING AND DEVELOPING MALOCCLUSION IN SIX TO TWELVE-YEAR-OLD CHILDREN – AN OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Rajendra Shirke 
Designation  2nd year, Post graduate student 
Affiliation  Dr. G. D. Pol Foundation Y.M.T. Dental, College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Department number 21, second floor, Y.M.T Dental College and Hospital, 18,Sector 4, Institutional area, Kharghar, Navi Mumbai
18,Sector 4, Institutional area, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
421202
India 
Phone  8097498647  
Fax    
Email  shweta.shirke6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amar Katre 
Designation  Professor 
Affiliation  DR. G. D. POL FOUNDATION Y.M.T. DENTAL COLLEGE AND HOSPITAL 
Address  Department of Pediatric and Preventive Dentistry, Department number 21, second floor, Y.M.T Dental College and Hospital, 18,Sector 4, Institutional area, Kharghar, Navi Mumbai
18,Sector 4, Institutional area, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
421202
India 
Phone  9821540186  
Fax    
Email  amar_katre@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Rajendra Shirke 
Designation  2nd year, Post graduate student 
Affiliation  DR. G. D. POL FOUNDATION Y.M.T. DENTAL COLLEGE AND HOSPITAL 
Address  Department of Pediatric and Preventive Dentistry, Department number 21, second floor, Y.M.T Dental College and Hospital, 18,Sector 4, Institutional area, Kharghar, Navi Mumbai
18,Sector 4, Institutional area, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
421202
India 
Phone  8097498647  
Fax    
Email  shweta.shirke6@gmail.com  
 
Source of Monetary or Material Support  
Y.M.T Dental College and Hospital Department of Pediatric and Preventive Dentistry, Department number 21, second floor, Y.M.T Dental College and Hospital, 18,Sector 4, Institutional area, Kharghar, Navi Mumbai 
 
Primary Sponsor  
Name  Dr Shweta Shirke 
Address  Department of Pediatric and Preventive Dentistry, Department number 21, second floor, Y.M.T Dental College and Hospital, 18,Sector 4, Institutional area, Kharghar, Navi Mumbai 
Type of Sponsor  Other [Self Sponsored, No External Sponsorship] 
 
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 Amar Katre  Dr. G. D. Pol Foundation Y.M.T Dental College and Hospital  Department of Pediatric and Preventive Dentistry, Department number 21, second floor, 18, Sector 4, Institutional area, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 		 9821540186
02227744427
amar_katre@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YMTRC INSTITUTIONAL REVIEW BOARD - ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Healthy children between the age group of 6 – 12 years.
2) Children with mixed dentition.
 
 
ExclusionCriteria 
Details  1) Children undergoing or completed orthodontic treatment.
2) Children with developmental syndromes like cleft lip and/or palate, etc.
3) Children in whom tonsillectomy/adenoidectomy has been performed.
4) Children undergoing medical care and presenting some type of neurological, neuromuscular or motor disturbances that would hinder their participation.
5) Children whose parents refused to give consent.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SDB
2. Type of Angle’s malocclusion
3. IOTN grade
 		 From 8/12/2018 to 30/04/2018
1. SDB (present or absent)
2. Type of Angle’s malocclusion (class I, class II, class III)
3. IOTN grade (GRADE 1-5)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Age
2. Gender
3. Tonsillar enlargement
4. degree of lingual mobility
5. maxillary frenal attachment
6.depth of palate  		 From 8/12/2018 to 30/04/2018
1. Age: in years
2. Gender: Male or Female
3. Tonsillar enlargement: Score 0 – 4 (based on Brodsky’s criteria)
4.Degree of lingual mobility Durans criteria (value 0-5)
5. Maxillary frenal attachment: Placeks criteria (mucosal, gingival, papillary, papillary penetrating)
6. Dept of palate: Palatal height was measured to the midline of the
palatal vault from a line between the second primary molars. 
 
Target Sample Size   Total Sample Size="161"
Sample Size from India="161" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 15/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Sinha D and Guilleminault C.: Sleep disordered breathing in children. Indian J Med Res. 2010; 131:311-20. . Carvalho F R, Lentini-Oliveira D A, Carvalho G M, Prado L B, Prado G F, and Carvalho L B.: Sleep-disordered breathing and orthodontic variables in children—pilot study. Int J Pediatr Otorhinolaryngol. 2014; 30;78(11):1965-9. 2014; 30;78(11):1965-9 . Nainan O, Jayan B, Mitra R, Ghosh S, Chopra SS, Mukherjee M. Dental Arch Morphology as a Predictor of Sleep Disordered Breathing. Sleep Hypn. 2017;19(2):30. Pirilä-Parkkinen K, Pirttiniemi P, Nieminen P, Tolonen U, Pelttari U and Löppönen H.: Dental arch morphology in children with sleep-disordered breathing. Eur J Orthod. 2008; 31(2):160-7. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In our study we are going to assess the association of Sleep Disordered Breathing (SDB) and developing malocclusion in six to twelve year old children. A written consent shall be obtained from the parent/s of children prior to the beginning of the study. 161 patients i.e. 6-12 year old children attending the OPD of the Dept. of Paediatric and Preventive Dentistry will be assessed for presence or absence of SDB through a 31 point questionnaire and type of developing Angle’s malocclusion.Complete general and oral examination will be performed using appropriate instruments. Tonsillar enlargement will be assessed using Brodsky’s criteria. Other variables such as degree of lingual mobility, maxillary frenal attachment, palatal depth will be also assessed. Impressions will be made and study models will be prepared and will be assessed for IOTN grades. IOTN index comprises of 5 grades, based on grades of treatment need. Relevant treatment will be given to the patients free of cost. 
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