| CTRI Number |
CTRI/2025/01/079654 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Sleep Patterns on Dental Health of Children: A Representative Sample Analysis |
|
Scientific Title of Study
|
The Association of Childhood Sleeping Habits with the Prevalence of Malocclusion, Traumatic Dental Injuries, Sleep Bruxism, Temporomandibular Disorders and Dental Caries: 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 |
Mukesh Kumar Dey |
| Designation |
Post Graduate Student |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
299 (MK Singh)
Eldeco Udyan II
Department no. 5
Department of Pediatric and Preventive Dentistry,
3rd Floor, Administrative Block,
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9085036196 |
| Fax |
|
| Email |
mukeshkumardey365@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonali Saha |
| Designation |
Professor & Director |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Department No. 5,
Department of Pediatric and Preventive Dentistry,
Sardar Patel Post Graduate Institute of Dental and Medical Sciences.
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9889234995 |
| Fax |
|
| Email |
drsonalisaha24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Kumar Dey |
| Designation |
Post Graduate Student |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
299 (MK Singh)
Eldeco Udyan II
Department no. 5
Department of Pediatric and Preventive Dentistry,
3rd Floor, Administrative Block,
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9085036196 |
| Fax |
|
| Email |
mukeshkumardey365@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Post Graduate Institute of Dental and Medical Sciences,
Administrative block, 3rd floor,
Department no. 5
Department of Pediatric and Preventive Dentistry |
|
|
Primary Sponsor
|
| Name |
Mukesh Kumar Dey |
| Address |
Department No. 5
Department of Pediatric and Preventive Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Mukesh Kumar Dey |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Department No. 5,
Department of Pediatric and Preventive Dentistry,
Administrative Block,
Sardar Patel Post Graduate Institute of Dental and Medical Sciences.
Lucknow
UTTAR PRADESH |
9085036196
mukeshkumardey365@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Parents/guardians of paediatric patients within the age range of 6-12 years.
Children who belong to the same parents/guardians.
Children with no systemic diseases.
Parents and children who agree to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients.
Patients who refuse to provide informed consent.
Patients who report under emergency orofacial conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Categorical variables will be
summarized as frequencies and continuous variables will be summarized as Means & Standard Deviations.
Inferential statistics will be comprised of chi square test,
Logistic regression & other suitable statistical tests.
The level of significance
was set at 0.05. |
3 months (i.e., at the end of study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "224"
Final Enrollment numbers achieved (India)="224" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This study is an observational cross-sectional trial evaluating the association of sleeping habits with traumatic dental injuries, presence of malocclusion, temporomandibular joint health, and dental caries in school children aged 6 to 12 years aimed to be conducted in a duration for 4 months in 224 patients visiting the OPD of the Department of Pediatric and Preventive Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow that will be conducted in the institutional department itself. The primary outcome measures will be to establish an association of children’s sleeping habits with traumatic dental injuries, presence of malocclusion, temporomandibular joint health, and dental caries. |