| CTRI Number |
CTRI/2025/06/089218 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Do Sleep Issues Harm Kids Teeth A Study on Childrens Oral Health
|
|
Scientific Title of Study
|
Evaluation of oral health parameters in children with and without sleep disorders: a clinical 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 |
Isha Gore |
| Designation |
Postgraduate student |
| Affiliation |
Nitte (Deemed to be University), AB Shetty Memorial Institute of Dental Sciences, Mangalore |
| Address |
Room no.15, 4thfloor, department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, NIthyanand Nagar, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7798755211 |
| Fax |
|
| Email |
dr.ishagore48206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vabitha Shetty |
| Designation |
Professor |
| Affiliation |
Nitte (Deemed to be University), AB AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE |
| Address |
ROOM NO-15, 4TH FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, NITHYANAND NAGAR,DERELAKATTE, MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
|
| Fax |
|
| Email |
docvabitha29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Isha Gore |
| Designation |
Postgraduate student |
| Affiliation |
Nitte (Deemed to be University), AB AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE |
| Address |
Room no-15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7798755211 |
| Fax |
|
| Email |
dr.ishagore48206@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Isha Gore |
| Address |
Room No-15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, NIthyanand Nagar, Derelakatte, Mangalore 575018, Dakshina Kannada, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Isha Gore |
AB Shetty Memorial Institute of Dental Sciences |
Room no-15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand nagar, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA |
7798755211
dr.ishagore48206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AB Shetty Memorial Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening intervention for children 6 to 11 years of age for sleep disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA FOR THE STUDY GROUP (Group 1):
1.Children of either gender aged 6-11 years.
2.Children with at least one sleep problem as determined by a validated sleep questionnaire.
3.Children with a retrognathic mandible and normal / prognathic maxilla.
4.Children with a reduced pharyngeal airway.
INCLUSION CRITERIA FOR THE CONTROL GROUP (Group 2):
1.Children of either gender aged 6-11 years.
2.Children with no history of sleep problems.
3. Children with a normal jaw relationship. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA FOR BOTH GROUPS:
1.Children with systemic and neurological disorders and/or cognitive deficit.
2.Children on medications that may affect their oral health such.
3.Children who have undergone professional fluoride treatment.
4.Children who use an antimicrobial mouth rinse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes of this study are the oral health parameters (salivary pH, buffering capacity, Streptococcus mutans counts, caries experience, gingival health and oral hygiene status) measured in children. These will be compared between hose with nd without sleep breathing disorders |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
29/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
This study aims to investigate the link between sleep breathing disorders and oral health status in children aged 6 to 11 years. It will involved comparing 35 children with a history of sleep breathing disorders ( study group) against 35 children without such history ( Control group). The primary goal is to evaluate various oral health parameters in both the groups. the parameters include salivary pH, buffering capacity, Streptococcus mutans counts, dental caries experience, gingival health and overall oral hygiene status. Data will be collected through questionnaires, clinical examination of oral cavity and laboratory analysis of saliva samples. the findings will help determine of oral health status significantly differs in the children affected by sleep disorders. |