Effect of Fibrin Sealant on Early Wound Healing (FS)

Chhattisgarh Dental College and Research Institute

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Drug: Suture; Drug: Fibrin Sealant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01538927

CDC0212-FS

CTRI/2012/05/002628 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Fibrin Sealant

Experimental group

Description:

One quadrant surgically elevated will be closed with fibrin sealant

Treatment:

Drug: Fibrin Sealant

Suture

Placebo Comparator group

Description:

The surgically elevated flap is closed with non resorbable sutures.

Treatment:

Drug: Suture