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CTRI Number  CTRI/2026/04/107253 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 31/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   “Study of Night-Time Teeth Grinding and Its Association with Sleep Habits and Daily Patterns in Young Children” 
Scientific Title of Study   Prevalence of Sleep Bruxism and its Association with Sleep Quality and different Chronotype Profiles of Preschool Children in Lucknow city: 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  NilamDeep Debbarma  
Designation  Postgraduate student  
Affiliation  Sardar Patel post graduate institute of dental and medical sciences 
Address  Department of pediatric and Preventive Dentistry, floor no.3, Sardar Patel post graduate institute of dental and medical sciences, Lucknow UTTAR PREADESH.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9233461026  
Fax    
Email  nilamdebbarma70@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sonali Saha 
Designation  Director and Professor 
Affiliation  Sardar Patel post graduate institute of dental and medical sciences 
Address  Department of pediatric and Preventive Dentistry, floor no.3, Sardar Patel post graduate institute of dental and medical sciences, Lucknow UTTAR PRADESH.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9889234995  
Fax    
Email  drsonalisaha24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NilamDeep Debbarma  
Designation  Postgraduate student  
Affiliation  Sardar Patel post graduate institute of dental and medical sciences 
Address  Department of pediatric and Preventive Dentistry, floor no.3, Sardar Patel post graduate institute of dental and medical sciences, Lucknow UTTAR PREADESH.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9233461026  
Fax    
Email  nilamdebbarma70@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr NilamDeep Debbarma 
Address  Sardar Patel Post graduate institute of Dental and Medical sciences, Lucknow, Uttar Pradesh, India, pin code-226025  
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 NilamDeep Debbarma   Sardar patel post graduate institute of dental and medical sciences  Department of pediatric and Preventive Dentistry, floor no.3, Sardar Patel post graduate institute of dental and medical sciences, Lucknow UTTAR PREADESH.
Lucknow
UTTAR PRADESH 
9233461026

nilamdebbarma70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy human volunteers with no health issues 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1)Children aged between 4–6 years.
2)Children of Indian nationality residing in Lucknow for approximately 6 years.
3)Parental/guardian consent obtained for participation
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identifying the prevalence will help understand how common sleep bruxism is in this population, as currently there is limited epidemiological data available in Indian preschool children, particularly in Lucknow. Establishing the prevalence will aid in early recognition of the condition, identification of potential risk factors, and development of preventive and management strategies by pediatric dentists and healthcare professionals.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the association between sleep bruxism and demographic variables among preschool children.

To evaluate the relationship between sleep bruxism and sleep characteristics.

To examine the association between sleep bruxism and chronotype profiles using the CIRENS scale.

To identify clinical and occlusal factors associated with sleep bruxism. 
2 years 
 
Target Sample Size   Total Sample Size="1044"
Sample Size from India="1044" 
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)   11/04/2026 
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  

Bruxism is a repetitive jaw-muscle activity with clenching or grinding of the teeth and/or by bracing or thrusting of the mandible. The term bruxism was derived from the Greek word ‘brychein’ meaning grinding the teeth. Marie, Pietkiewicz in 1907 used the term ‘la bruxomanie’ in French.

This condition affects both children and adults. Bruxism has two distinct circadian manifestations. It can occur during waking hours (Day Time Bruxism/Diurnal bruxism /Awake Bruxism) or during sleep (Nighttime bruxism/Nocturnal bruxism/ sleep bruxism).

The global bruxism (sleep and awake) prevalence is 22.22%. The global sleep bruxism prevalence is 21% and awake prevalence is 23%.The onset of sleep bruxism is about 1 year of age soon after the eruption of deciduous incisors. The prevalence of sleep bruxism is reported to be 10-20% in children. In preschool children, it is found to be prevalent at 14% and it decreases with advancing age. In young adults aged between 18 and 29 years, it is 13% and 3% in individuals over 60 years of age. The disorder appears more in children with primary dentition. It is usually short-term; often stops by the time secondary dentition erupts.

The etiology of bruxism is multifactorial. It includes psychological/ behavioral factors such as stress and anxiety. Social factors like divorced/Single parents, problems at school, high expectation of academic performance by teachers/parents, abusive environment of the child, the birth of a sibling can also contribute to bruxism. Systemic factors such as allergies, asthma, intestinal parasite infestation, nutritional or endocrine disorders, and dental factors like malocclusion, TMJ dysfunction can be causative towards bruxism.

Although the condition is self-limiting in many children, it may contribute to tooth wear, enamel loss, tooth sensitivity, muscular discomfort, TMJ pain, and disturbed sleep quality. Furthermore, bruxism may reflect underlying behavioural or psychological stress, making it a useful early marker of psychosocial issue in children.

Lucknow, as a major urban and educational centre in northern India, represents a diverse pediatric population increasingly exposed to modern lifestyle patterns such as extended screen use, irregular sleep schedules, heightened academic expectations, and changing family dynamics—all of which may influence children’s sleep quality and behavior. These conditions may predispose preschool children to sleep disturbances and bruxism. Despite its clinical relevance, there are no published studies from Lucknow evaluating the prevalence and associated factors of sleep bruxism among children. However, there is a paucity of Indian data exploring this condition among preschool aged children. Most Indian studies focus on school-aged populations, leaving a significant gap in understanding its occurrence during early childhood a period when parafunctional habits typically originate.

 
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