| CTRI Number |
CTRI/2011/05/001759 [Registered on: 25/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
20/05/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a suture alternative in use in gum surgeries. |
|
Scientific Title of Study
|
Fibrin Sealant Versus Sutures In Periodontal Flap Surgery: A Histo- Morphometric Randomized Pilot Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CDC11/FG |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaju Jacob P |
| Designation |
Associate Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Chhattisgarh Dental College and Research Institute
Sundra
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
07744281930 |
| Fax |
07744281930 |
| Email |
shajujacob@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaju Jacob P |
| Designation |
Associate Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Chhattisgarh Dental College and Research Institute
Sundra
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
07744281930 |
| Fax |
07744281930 |
| Email |
shajujacob@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaju Jacob P |
| Designation |
Associate Professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Chhattisgarh Dental College and Research Institute
Sundra
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
07744281930 |
| Fax |
07744281930 |
| Email |
shajujacob@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Principal Investigator |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, 491441, India |
| 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 |
| Shaju Jacob P |
Chhattisgarh Dental College and Research Institute |
Sundra,Rajnandgaon-491441
Rajnandgaon
CHHATTISGARH |
07744281930
07744281930
shajujacob@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh Dental College and Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Periodontal tissue healing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
4-0 Silk suture |
Silk suture is a suturing material used to hold incised tissues together usually in aseptic surgical procedures |
| Intervention |
Fibrin glue (sealant) |
Fibrin sealant is a human blood derivative used as a adhesive to join incised tissues usually in aseptic surgical procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 and 60 years with periodontitis requiring periodontal flap surgery in at least two quadrants in a single arch of the mouth. |
|
| ExclusionCriteria |
| Details |
Pregnancy, diabetes, immune disorders, blood disorders, on antibiotics in recent 3 months. |
|
|
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 |
| histological Periodontal tissue healing. |
8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical healing |
8th and 15th day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/02/2011 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 tries to find the efficacy of fibrin glue (sealant) as a periodontal flap closure agent comparing against the usual practice of suturing. the study is done as a pilot trial on 10 patients with periodontitis requiring surgery. Tissue healing is evaluated histologically at the 8th day following surgery. |