Trial | NCT01538927  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    human fibrin ...

  • Study Participants

    15
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 Started
Apr 30
2012
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Dec 25
2012
Estimate

Drug Fibrin Sealant

Fibrin Sealant 4ml (Baxter Tisseel)

  • Other names: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated

Drug Suture

Black silk 000

  • Other names: Ethicon

Fibrin Sealant Experimental

One quadrant surgically elevated will be closed with fibrin sealant

Suture Placebo Comparator

The surgically elevated flap is closed with non resorbable sutures.

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.
No Results Posted