| CTRI Number |
CTRI/2018/01/011294 [Registered on: 12/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of biting forces in gum infection patients |
|
Scientific Title of Study
|
Quantitative analysis of occlusal forces using dental prescale system in patients with periodontal diseases. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashank Mishra |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Sai college of Dental Surgery |
| Address |
Room no 3
Dept of Periodontics
Sri Sai College of Dental Surgery,
Kothrepally, Vikarabad, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH
501101
India |
| Phone |
9866205958 |
| Fax |
|
| Email |
drashankmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHANK MISHRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Sai college of Dental Surgery |
| Address |
Room no 3
Dept of Periodontics
Sri Sai College of Dental Surgery,
Kothrepally, Vikarabad, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH
501101
India |
| Phone |
9652455811 |
| Fax |
|
| Email |
drashankmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Ashank Mishra |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Sai college of Dental Surgery |
| Address |
Room no 3
Dept of Periodontics
Sri Sai College of Dental Surgery,
Kothrepally, Vikarabad, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH
501101
India |
| Phone |
9866205958 |
| Fax |
|
| Email |
drashankmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVM Meditech private ltd
T 302-303
Chetak complex
Dilshad garden
New Delhi
110095
INDIA |
|
|
Primary Sponsor
|
| Name |
DR ASHANK MISHRA |
| Address |
Room no 3dept of periodontics
sri sai college of dental surgery
vikarabad |
| Type of Sponsor |
Other [] |
|
|
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 ASHANK MISHRA |
sri sai college of dental surgery |
Room no 3
Dept of Periodontics
Sri Sai College of Dental Surgery,
Kothrepally, Vikarabad, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH |
9866205958
9652455811
drashankmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri sai college of dental surgery |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
periodontitis and periodontally healthy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
chronic generalized periodontitis
periodonally healthy
|
|
| ExclusionCriteria |
| Details |
prosthesis
missing teeth |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
to determine occlusal load
maximal bite force in periodontitis patients |
cross sectional
the point when patient is recruited |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occlusal load and pressure |
once
when patient d recruited |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
10/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
25 periodontitis patients and 25 periodontally healthy patients were recruited. The bite force was recorded using prescale sheets and sent for analysis. The results revealed statistically significant difference between pressure and loadbetween both groups . It can be concluded that periodontitis group has less occlusal load compared to healthy. |