| CTRI Number |
CTRI/2012/05/002628 [Registered on: 07/05/2012] Trial Registered Prospectively |
| Last Modified On: |
22/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Fibrin Sealant on Early Wound Healing (FS) |
|
Scientific Title of Study
|
Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01538927 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaju Jacob P |
| Designation |
Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Department of Periodontology, Room No 8
Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
|
| Fax |
|
| Email |
shajujacob@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaju Jacob P |
| Designation |
Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Sundra, Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
|
| Fax |
|
| Email |
shajujacob@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaju Jacob P |
| Designation |
Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Sundra, Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
|
| Fax |
|
| Email |
shajujacob@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Baxter Health care corporation |
|
|
Primary Sponsor
|
| Name |
Chhattisgarh Dental College and Research Institute |
| Address |
Sundra, Rajnandgaon, Chhattisgarh |
| Type of Sponsor |
Other [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 |
| Shaju Jacob |
Chhattisgarh Dental College and Research Institute |
Department of Periodontology,
Room No 8
Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH |
07744281930
07744281930
shajujacob@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Silk suture |
Suture is used as a comparator for periodontal flap closure |
| Intervention |
Tisseel Fibrin Sealant |
Fibrin sealant (FS) is a human derived substance used to create fibrin clot. It is composed of fibrinogen and thrombin where thrombin acts as an enzyme and converts the fibrinogen to fibrin which then can act as a tissue adhesive. It mimics the last step of the clotting cascade leading to fibrin clot. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥6mm and is indicated for periodontal flap surgery. |
|
| ExclusionCriteria |
| Details |
1. History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
2. Current or former smokers.
3. Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
4. Mobility of selected teeth.
5. Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GCF levels of interleukin 1beta and 6 |
assessed at the 8th day after periodontal surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical healing |
8, 14, 28 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Fibrin sealant is used in periodontal surgery as an alternative to sutures. The trial tries to see the early wound healing property of the fibrin sealant for closure of periodontal flaps by evaluating proinflammatory markers, IL 1 beta and IL 6.
|