| CTRI Number |
CTRI/2017/05/008619 [Registered on: 23/05/2017] Trial Registered Prospectively |
| Last Modified On: |
23/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
stress assessment using saliva in minor oral surgery |
|
Scientific Title of Study
|
Evaluation of cortisol concentration in saliva and its correlation with hemodynamic parameters as a measure of stress during minor oral surgical procedure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gadicherla Srikanth |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room number 4, Department of oral and Maxillofacial surgery, ground floor
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gadicherla Srikanth |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room number 4, Department of Oral and maxillofacial surgery, madhav nagar, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gadicherla Srikanth |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room number 4, Department of Oral and maxillofacial surgery, madhav nagar, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Koye Pharmaceuticals Pvt ltd,
7, The Centrium,
Phoenix Market City Annexe,
LBS Marg,
Mumbai |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Madhave Nagar, Manipal |
| 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 |
| Gadicherla Srikanth |
Manipal College of Dental Sciences, Manipal |
Room number 4, Department of Oral and maxillofacial surgery, madhav nagar, Manipal
Udupi
KARNATAKA |
9986455201
gadi_mds@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Kasturba Hopsital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who would need minor oral surgical procedures would be included for the study group. Healthy subjects who dont require any dental treatments would be recruited for control group., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who would need minor oral surgical procedures would be included for study group and who do not require any dental treatment would be recruited as control group. |
|
| ExclusionCriteria |
| Details |
Subjects with syndromes or medical comorbidities or comprehension problems would be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary cortisol concentration |
salivary cortisol concentration 5 mins before and immediately 5 mins after minor oral surgical procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic parameters like blood pressure and heart rate |
5 mins before, 5 mins after the minor oral surgical procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/05/2017 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a cross-sectional observational study which evaluates the saliva cortisol from subjects before and after minor oral surgical procedures and compared with control subjects. Hemodynamic parameters like heart rate and blood pressure will be evaluated. It will help to understand the amount of stress involved in minor oral surgical procedures and its correlation with hemodynamic parameters. |