| 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
|
|
|
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
|
|
|
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. |