| CTRI Number |
CTRI/2024/02/062957 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking the Health of Gums in People Who Might Grind Their Teeth: A Detailed Study |
|
Scientific Title of Study
|
Evaluating The Periodontal Status Of Patient With Probable Bruxism : 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 |
Dr Sohini Dingal |
| Designation |
Post Graduate Student |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
room no 223, Department of periodontics.
Institute Of Dental Sciences, bareilly, Pilibhit Bypass Road Chandpur Bichpuri.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
08972144574 |
| Fax |
|
| Email |
dingalsohini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rika Singh |
| Designation |
Professor |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
room no 223, department of periodontics.
Institute Of Dental Sciences, bareilly, Pilibhit Bypass Road Chandpur Bichpuri.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8171653609 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohini Dingal |
| Designation |
Post Graduate Student |
| Affiliation |
Institute Of Dental Sciences, Bareilly |
| Address |
Institute Of Dental Sciences, bareilly, Pilibhit Bypass Road Chandpur Bichpuri.
Institute Of Dental Sciences, bareilly, Pilibhit Bypass Road Chandpur Bichpuri.
UTTAR PRADESH
243006
India |
| Phone |
08972144574 |
| Fax |
|
| Email |
dingalsohini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Dental Sciences, bareilly |
|
|
Primary Sponsor
|
| Name |
Institute Of Dental Sciences, Bareilly |
| Address |
pilibhit bypass road, chandpur bichpuri, bareilly |
| 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 Sohini Dingal |
room no 223 |
Institute Of Dental Sciences, Pilibhit Bypass Road Chandpur Bichpuri
Bareilly
UTTAR PRADESH |
8972144574
dingalsohini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IDS, Bareilly, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 18-50 years.
Patients seeking periodontal care. |
|
| ExclusionCriteria |
| Details |
Systemically compromised patients e.g., Diabetes Mellitus, Cardiovascular disorders etc.
Patients who will be on medications that could interfere with wound healing and bone metabolism.
Edentulous patients
Patients with Orofacial muscular deformities. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal condition in bruxism patients and periodontitis patient |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
25/04/2024 |
| 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="6"
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
|
Bruxism is a comprehensive term linked to various factors and influenced by the central nervous system. While the potential adverse effects of bruxism on temporomandibular joints, chewing muscles, and natural teeth have been discussed over recent years, the impact of excessive occlusal force on the periodontium remains unclear and debated. This prompted the current cross-sectional study, aimed at determining the prevalence of probable bruxism in adults and investigating its potential association with periodontal status. Patients seeking periodontal care at Department of periodontology unit will be considered in this study. Informed consent will be obtained from the selected patients. A format of questionaire will be given to each patients for obtaining answers . Their Tooth Mobility, Attrition, Clinical attachment level (CAL), Gingival Recession Width, Probing pocket depth will be recorded. |