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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538927

Acronym

Enrollment

Registered

2012-02-24

Start date

2012-04-30

Completion date

2012-12-31

Last updated

2012-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8

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.

Interventions

DRUGFibrin Sealant

Fibrin Sealant 4ml (Baxter Tisseel)

DRUGSuture

Black silk 000

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Clinical inflammation	7, 14 and 21 days	Gingival inflammation will be assessed at a clinical level.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026