Effect of Fibrin Sealant on Early Wound Healing (FS)

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute
ClinicalTrials.gov Identifier:
NCT01538927
First received: February 10, 2012
Last updated: December 22, 2012
Last verified: December 2012

February 10, 2012
December 22, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
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.
Concentration of cytokines. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assess the concentration of Interleukin 1beta, Interleukin 8 and Transforming Growth Factor 1 beta in GCF of test and control sites after 7 days.
Complete list of historical versions of study NCT01538927 on ClinicalTrials.gov Archive Site
Clinical inflammation [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]
Gingival inflammation will be assessed at a clinical level.
Same as current
Not Provided
Not Provided
 
Effect of Fibrin Sealant on Early Wound Healing
Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Periodontitis
  • Drug: Fibrin Sealant
    Fibrin Sealant 4ml (Baxter Tisseel)
    Other Name: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
  • Drug: Suture
    Black silk 000
    Other Name: Ethicon
  • Experimental: Fibrin Sealant
    One quadrant surgically elevated will be closed with fibrin sealant
    Intervention: Drug: Fibrin Sealant
  • Placebo Comparator: Suture
    The surgically elevated flap is closed with non resorbable sutures.
    Intervention: Drug: Suture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A subject has to be between the ages of 18 and 60 years.
  2. 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.
  3. Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
  4. Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
  5. Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
  6. Endodontic status: Teeth had to be vital or properly treated with root canal therapy

Exclusion Criteria:

  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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01538927
CDC0212-FS, CTRI/2012/05/002628
No
Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute
Chhattisgarh Dental College and Research Institute
Baxter Healthcare Corporation
Principal Investigator: Shaju P Jacob, MDS Chhattisgarh Dental College and Research Institute
Chhattisgarh Dental College and Research Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP