| CTRI Number |
CTRI/2019/01/017363 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
31/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimation of Biomarkers in Crevicular Fluid around implants and its Correlation with bleeding on probing and probing depth |
|
Scientific Title of Study
|
Estimation of Osteoprotegerin Levels in Peri-Implant Crevicular Fluid and its Correlation with Clinical Parameters: An in Vivo Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal jain |
| Designation |
Post Graduate Student |
| Affiliation |
Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences |
| Address |
Room no. 4, Dept. of Prosthodontics, Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences,New BEL ROAD, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9538913412 |
| Fax |
|
| Email |
jainsheetal950@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vibha Shetty |
| Designation |
Senior Professor |
| Affiliation |
Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences |
| Address |
Room no. 4, Dept. of Prosthodontics, Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences,New BEL ROAD, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9845305455 |
| Fax |
|
| Email |
vibshetty6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibha Shetty |
| Designation |
Senior Professor |
| Affiliation |
Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences |
| Address |
Room no. 4, Dept. of Prosthodontics, Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences,New BEL ROAD, Bengaluru
KARNATAKA
560054
India |
| Phone |
9845305455 |
| Fax |
|
| Email |
vibshetty6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, MSRUAS, Central Research Laboratory, MSRTH |
|
|
Primary Sponsor
|
| Name |
Dr Sheetal Jain |
| Address |
No.4, Dept. of Prosthodontics, Faculty of Dental Sciences, MSRUAS, New BEL Road, Bangalore 560054 |
| 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 |
| Sheetal Jain |
Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences |
Room no. 4, Dept. of Prosthodontics, Faculty of Dental Sciences, M. S. Ramaiah University of Applied Sciences,New BEL ROAD, Bengaluru
Bangalore
KARNATAKA |
9538913412
jainsheetal950@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human Trials, MSRUAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Missing teeth with atleast one dental implant used for replacement |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years with good oral hygiene and atleast one dental implant, systemically healthy patients |
|
| ExclusionCriteria |
| Details |
Patients with history of smoking, bruxism or any parafunctional habit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate OPG levels from 3 months to 5 months |
Evaluate OPG levels from 3 months to 5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate OPG levels at 3 months after implant placement |
3 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/02/2019 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aims to estimate Osteoprotegerin (OPG) levels in peri implant crevicular fluid and gingival crevicular fluid around implants and teeth in the same individual and its corelation with clinical parameters. A total of 60 PICF and GCF samples will be collected from 15 patients at 3 and 5 months intervals after implant placement and OPG concentration will be analysed using ELISA. Clinical parameters such as bleeding on probing and probing depth will be evaluated and compared with OPG levels in PICF and GCF. The results will be analysed and compared using Wilcoxin signed rank test, McNemar’s test and Spearman’s corelation test. |