Effect of Fibrin Sealant on Early Wound Healing

Periodontitis Clinical Trial

— FS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538927
• Other study ID #: CDC0212-FS
• Secondary ID: CTRI/2012/05/002
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2012
• Last updated: December 22, 2012
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Chhattisgarh Dental College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board, Board of Research on Humans
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. A subject has to be between the ages of 18 and 60 years.

2. 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.

3. Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.

4. Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.

5. Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.

6. Endodontic status: Teeth had to be vital or properly treated with root canal therapy

Exclusion Criteria:

1. History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.

2. Current or former smokers.

3. Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.

4. Mobility of selected teeth.

5. Pregnant or lactating women.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Fibrin Sealant
Fibrin Sealant 4ml (Baxter Tisseel)
• Suture
Black silk 000

Locations

Country	Name	City	State
India	Chhattisgarh Dental College and Research Institute	Raj Nandgaon	Chhattisgarh

Sponsors (2)

Lead Sponsor	Collaborator
Chhattisgarh Dental College and Research Institute	Baxter Healthcare Corporation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of cytokines.	Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.	7 days	No
Secondary	Clinical inflammation	Gingival inflammation will be assessed at a clinical level.	7, 14 and 21 days	No