FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064436 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of night time brushing on sleep quality 
Scientific Title of Study   Evaluation of the effect of night time brushing on sleep quality using Mat-type sleep analyzer: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vineet Sharma 
Designation  Professor 
Affiliation  Army Dental Centre (Research and Referral) 
Address  Room No: ORTH 1 Department: Department of Orthodontics and Dentofacial Orthopaedics Army Dental Centre (Research and Referral) Delhi Cantt

New Delhi
DELHI
110010
India 
Phone  9596744222  
Fax    
Email  vintee65@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vineet Sharma 
Designation  Professor 
Affiliation  Army Dental Centre (Research and Referral) 
Address  Room No: ORTH 1 Department: Department of Orthodontics and Dentofacial Orthopaedics Army Dental Centre (Research and Referral) Delhi Cantt 110010

New Delhi
DELHI
110010
India 
Phone  9596744222  
Fax    
Email  vintee65@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Parvinder Sharma 
Designation  Lt Col 
Affiliation  Army Dental Corps 
Address  Room No 20 Department: Centre for Advanced Maxillofacial Research Division: CRMM INMAS, DRDO Timarpur

North
DELHI
110054
India 
Phone  8989505251  
Fax    
Email  sharmaparvinder@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Funding Agency Office of DGDS (Director General Dental Services) Army Dental Corps 
 
Primary Sponsor  
Name  Army Dental Centre Research and Referral 
Address  Delhi Cantt New Delhi 110010 110010 
Type of Sponsor  Government funding agency 
 
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 Vineet Sharma  Army Dental Centre (Research & Referral)  Room No: ORTH 1 Department: Department of Orthodontics and Dentofacial Orthopaedics Army Dental Centre (Research and Referral) Delhi Cantt
New Delhi
DELHI 
9596744222

vintee65@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Human Ethical Committee Army Dental Centre (RR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Effect of night time brushing on sleep quality 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Night-time brushing to be advised   Participants will be instructed to follow brushing before sleep. Sleep quality will be recorded for 07 days with the intervention. 
Intervention  No instructions for night time brushing  No instructions for night time brushing during the study and sleep quality will be recorded for 07 days. 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children who don’t brush at night.
2. Children not experiencing sleep disturbances or suboptimal sleep quality, as indicated by self-report (The Pittsburgh sleep quality index).
3. Participants should not have any significant underlying medical conditions that could affect sleep quality (e.g., chronic pain, respiratory disorders, psychiatric disorders).
4. Participants must be committed to attending follow-up assessments and adhering to the study protocol.
 
 
ExclusionCriteria 
Details  1. Individuals with diagnosed sleep disorders.
2. Individuals currently using prescription sleep medications or other substances that could significantly affect sleep quality.
3. Individuals with physical disabilities that could hinder the proper use of the Sleep Analyzer.
4. Individuals who have undergone recent oral surgeries, extractions, or dental procedures that could affect their ability to adhere to oral hygiene interventions.
5. Individuals participating in other clinical trials or studies that could interfere with the results of the current study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine whether night-time brushing improves sleep quality.
2. To determine if there is a significant difference in sleep quality after night-time brushing.
 
24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between night time brushing and sleep quality  24 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/04/2024 
Date of Study Completion (India) 10/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Sleep, a fundamental and complex physiological process, is integral to overall well-being, with its significance extending beyond the realms of rest and rejuvenation. Concurrently, oral health, encompassing the condition of the oral cavity and its structures, plays a pivotal role in an individual’s general health status. While these two domains may appear disparate at first glance, the evidence suggests a multifaceted relationship, whereby disturbances in one may significantly impact the other. Effect of sleep on oral health has been studied and documented, but the converse has not been focused. Research on the impact of oral biome-brain axis is still in the nascent stage. Understanding the intricate relationship between sleep quality and oral health holds significant clinical and public health implications. Unraveling the underlying mechanisms and identifying potential intervention strategies could pave the way for comprehensive approaches to improve both sleep quality and oral health, ultimately enhancing overall well-being. The proposed study will be carried out to assess the effect of night-time brushing on sleep quality of 80 healthy children between 08-18 years of age using under-the-mattress sleep analyzer.

 
Close