FS: Effect of Fibrin Sealant on Early Wound Healing

Sponsor

Chhattisgarh Dental College and Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01538927

Collaborator

Baxter Healthcare Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Drug: Fibrin Sealant Drug: Suture	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Concentration of cytokines. [7 days]
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.

Secondary Outcome Measures

Clinical inflammation [7, 14 and 21 days]
Gingival inflammation will be assessed at a clinical level.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.