Back to resultsEffect of Fibrin Sealant on Early Wound Healing (FS)
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Fibrin Sealant
Suture
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8
Eligibility Criteria
Inclusion Criteria:
- A subject has to be between the ages of 18 and 60 years.
- 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.
- Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
- Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
- Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
- Endodontic status: Teeth had to be vital or properly treated with root canal therapy
Exclusion Criteria:
- History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Current or former smokers.
- Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
- Mobility of selected teeth.
- Pregnant or lactating women.
Sites / Locations
- Chhattisgarh Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fibrin Sealant
Suture
Arm Description
One quadrant surgically elevated will be closed with fibrin sealant
The surgically elevated flap is closed with non resorbable sutures.
Outcomes
Primary Outcome Measures
Concentration of cytokines.
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
Secondary Outcome Measures
Clinical inflammation
Gingival inflammation will be assessed at a clinical level.
Full Information
NCT ID
NCT01538927
First Posted
February 10, 2012
Last Updated
December 22, 2012
Sponsor
Chhattisgarh Dental College and Research Institute
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01538927
Brief Title
Effect of Fibrin Sealant on Early Wound Healing
Acronym
FS
Official Title
Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chhattisgarh Dental College and Research Institute
Collaborators
Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fibrin Sealant
Arm Type
Experimental
Arm Description
One quadrant surgically elevated will be closed with fibrin sealant
Arm Title
Suture
Arm Type
Placebo Comparator
Arm Description
The surgically elevated flap is closed with non resorbable sutures.
Intervention Type
Drug
Intervention Name(s)
Fibrin Sealant
Other Intervention Name(s)
TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
Intervention Description
Fibrin Sealant 4ml (Baxter Tisseel)
Intervention Type
Drug
Intervention Name(s)
Suture
Other Intervention Name(s)
Ethicon
Intervention Description
Black silk 000
Primary Outcome Measure Information:
Title
Concentration of cytokines.
Description
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Clinical inflammation
Description
Gingival inflammation will be assessed at a clinical level.
Time Frame
7, 14 and 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A subject has to be between the ages of 18 and 60 years.
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.
Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
Endodontic status: Teeth had to be vital or properly treated with root canal therapy
Exclusion Criteria:
History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
Current or former smokers.
Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
Mobility of selected teeth.
Pregnant or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaju P Jacob, MDS
Organizational Affiliation
Chhattisgarh Dental College and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chhattisgarh Dental College and Research Institute
City
Raj Nandgaon
State/Province
Chhattisgarh
ZIP/Postal Code
491441
Country
India
12. IPD Sharing Statement
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Effect of Fibrin Sealant on Early Wound Healing
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