Effect of Fibrin Sealant on Early Wound Healing (FS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01538927
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : December 25, 2012
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Periodontitis Drug: Fibrin Sealant Drug: Suture Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Suture
Black silk 000
Other Name: Ethicon

Primary Outcome Measures :
  1. Concentration of cytokines. [ Time Frame: 7 days ]
    Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.

Secondary Outcome Measures :
  1. Clinical inflammation [ Time Frame: 7, 14 and 21 days ]
    Gingival inflammation will be assessed at a clinical level.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01538927

Chhattisgarh Dental College and Research Institute
Raj Nandgaon, Chhattisgarh, India, 491441
Sponsors and Collaborators
Chhattisgarh Dental College and Research Institute
Baxter Healthcare Corporation
Principal Investigator: Shaju P Jacob, MDS Chhattisgarh Dental College and Research Institute

Responsible Party: Dr Shaju Jacob P, Professor, Chhattisgarh Dental College and Research Institute Identifier: NCT01538927     History of Changes
Other Study ID Numbers: CDC0212-FS
CTRI/2012/05/002628 ( Registry Identifier: Clinical Trials Registry - India )
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: December 25, 2012
Last Verified: December 2012

Keywords provided by Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute:
fibrin sealant
tissue adhesive
wound healing
interleukin 1 beta
interleukin 8

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fibrin Tissue Adhesive