| CTRI Number |
CTRI/2024/07/071496 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess the variations in attachment and morphology of maxillary labial frenum and its association with oral hygiene status in pediatric patients. |
|
Scientific Title of Study
|
Assessment of variation in morphology and attachment of maxillary labial frenum and its association with oral hygiene status in primary dentition-an observational 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 |
Dr Tanvi S |
| Designation |
postgraduation |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry, The Oxford Dental College, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9591079864 |
| Fax |
|
| Email |
drtanvishashi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry, The Oxford Dental College, Bengaluru.
Bangalore
KARNATAKA
560068
India |
| Phone |
9731196369 |
| Fax |
|
| Email |
drkkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi S |
| Designation |
postgraduation |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry, The Oxford Dental College, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9591079864 |
| Fax |
|
| Email |
drtanvishashi@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Bangalore, Karnataka 560068 |
|
|
Primary Sponsor
|
| Name |
The Oxford Dental College |
| Address |
Hosur road, Bommanahalli, NH 44, Hongasandra, Bangalore 560068 |
| 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 Kiran K |
The Oxford Dental College |
Department of Pediatric and Preventive Dentistry, Room no. 8
Bangalore
KARNATAKA |
9731196369
drkkiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee The Oxford Dental College (IEC-TODC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative children aged between 2-6 years having normal primary dentition with no or minimal crowding.
Children with both the primary maxillary central incisors present.
Children with maxillary labial frenum present. |
|
| ExclusionCriteria |
| Details |
Absence of maxillary labial frenum.
Children with any systemic illness and congenital/developmental defects.
History of trauma/injury in the premaxillary region.
Children with loss of primary maxillary anterior teeth following trauma.
Children under any medication known to affect the gingiva. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of type of attachment and morphology of maxillary labial frenum.
Oral hygiene status of children. |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of type of attachment & morphology of maxillary labial frenum with oral hygiene status |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="1030"
Sample Size from India="1030"
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)
|
06/08/2024 |
| 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="0"
Months="4"
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
|
This study is an observational study where 1030 participants will be selected randomly and clinically examied on dental chair for maxillary labial frenum attachment and its morphology by direct visual method under artificial light. Blanch test will be done to detect the high frenum attachment. And its association with oral hygiene status will be determined in each individual. |