Effect of Fibrin Sealant on Early Wound Healing

Phase 4

Completed

• Conditions: Periodontitis
• Interventions: Drug: Suture; Drug: Fibrin Sealant

• Registration Number: NCT01538927
• Lead Sponsor: Chhattisgarh Dental College and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-18
• Study First Posted: 2012-02-24
• Study Start: 2012-04
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-22
• Last Update Posted: 2012-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Suture	The surgically elevated flap is closed with non resorbable sutures.
Fibrin Sealant	Fibrin Sealant	One quadrant surgically elevated will be closed with fibrin sealant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical inflammation	7, 14 and 21 days	Gingival inflammation will be assessed at a clinical level.

Trial Locations

Locations (1)

Chhattisgarh Dental College and Research Institute; 🇮🇳 Raj Nandgaon, Chhattisgarh, India