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
  Purpose

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 Intervention Phase
Periodontitis
Drug: Fibrin Sealant
Drug: Suture
Phase 4

Study Type: Interventional
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.

Further study details as provided by Chhattisgarh Dental College and Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Clinical inflammation [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]
    Gingival inflammation will be assessed at a clinical level.


Estimated Enrollment: 15
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538927

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

No publications provided

Responsible Party: Dr Shaju Jacob P, Professor, Chhattisgarh Dental College and Research Institute
ClinicalTrials.gov Identifier: NCT01538927     History of Changes
Other Study ID Numbers: CDC0212-FS, CTRI/2012/05/002628
Study First Received: February 10, 2012
Last Updated: December 22, 2012
Health Authority: India: Institutional Review Board, Board of Research on Humans

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

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014