| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |