Effect of Fibrin Sealant on Early Wound Healing

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Fibrin Sealant
* Drug: Suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin Sealant<br>One quadrant surgically elevated will be closed with fibrin sealant | Drug: Fibrin Sealant<br>* Fibrin Sealant 4ml (Baxter Tisseel)<br>* Other names: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated;|
| Placebo Comparator: Suture<br>The surgically elevated flap is closed with non resorbable sutures. | Drug: Suture<br>* Black silk 000<br>* Other names: Ethicon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of cytokines. | 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 | Gingival inflammation will be assessed at a clinical level. | 7, 14 and 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8