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Completed

NCT Number: NCT01538927

Effect of Fibrin Sealant on Early Wound Healing

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chhattisgarh Dental College and Research Institute

Rāj-Nāndgaon, Chhattisgarh, 491441, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibrin Sealant

Drug

Fibrin Sealant 4ml (Baxter Tisseel)

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

Suture

Drug

Black silk 000

Other names: Ethicon

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical inflammation

    Time frame: 7, 14 and 21 days

    Gingival inflammation will be assessed at a clinical level.

Sponsors and collaborators

Lead sponsor

Chhattisgarh Dental College and Research Institute

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Acronym: FS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2012
Registry last updated
Dec 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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