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Effect of Fibrin Sealant on Early Wound Healing

NCT ID: NCT01538927

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Periodontitis

Keywords

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fibrin sealant tissue adhesive wound healing interleukin 1 beta interleukin 8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fibrin Sealant

One quadrant surgically elevated will be closed with fibrin sealant

Group Type EXPERIMENTAL

Fibrin Sealant

Intervention Type DRUG

Fibrin Sealant 4ml (Baxter Tisseel)

Suture

The surgically elevated flap is closed with non resorbable sutures.

Group Type PLACEBO_COMPARATOR

Suture

Intervention Type DRUG

Black silk 000

Interventions

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Fibrin Sealant

Fibrin Sealant 4ml (Baxter Tisseel)

Intervention Type DRUG

Suture

Black silk 000

Intervention Type DRUG

Other Intervention Names

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TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated Ethicon

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Chhattisgarh Dental College and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Shaju Jacob P

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaju P Jacob, MDS

Role: PRINCIPAL_INVESTIGATOR

Chhattisgarh Dental College and Research Institute

Locations

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Chhattisgarh Dental College and Research Institute

Rāj-Nāndgaon, Chhattisgarh, India

Site Status

Countries

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India

Other Identifiers

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CTRI/2012/05/002628

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDC0212-FS

Identifier Type: -

Identifier Source: org_study_id