Effect of Fibrin Sealant on Early Wound Healing (FS)
The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.
Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.|
- Concentration of cytokines. [ Time Frame: 7 days ] [ Designated as safety issue: No ]Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
- Clinical inflammation [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]Gingival inflammation will be assessed at a clinical level.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Fibrin Sealant
One quadrant surgically elevated will be closed with fibrin sealant
Drug: Fibrin Sealant
Fibrin Sealant 4ml (Baxter Tisseel)
Other Name: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
Placebo Comparator: Suture
The surgically elevated flap is closed with non resorbable sutures.
Black silk 000
Other Name: Ethicon
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538927
|Chhattisgarh Dental College and Research Institute|
|Raj Nandgaon, Chhattisgarh, India, 491441|
|Principal Investigator:||Shaju P Jacob, MDS||Chhattisgarh Dental College and Research Institute|