Effect of Fibrin Sealant on Early Wound Healing (FS)

December 22, 2012 updated by: Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chhattisgarh
      • Raj Nandgaon, Chhattisgarh, India, 491441
        • Chhattisgarh Dental College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ethicon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical inflammation
Time Frame: 7, 14 and 21 days
Gingival inflammation will be assessed at a clinical level.
7, 14 and 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chhattisgarh Dental College and Research Institute

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Shaju P Jacob, MDS, Chhattisgarh Dental College and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 18, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Estimate)

December 25, 2012

Last Update Submitted That Met QC Criteria

December 22, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC0212-FS
  • CTRI/2012/05/002628 (Registry Identifier: Clinical Trials Registry - India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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