Periodontitis Clinical Trial
— FSOfficial title:
Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Chhattisgarh Dental College and Research Institute | Raj Nandgaon | Chhattisgarh |
Lead Sponsor | Collaborator |
---|---|
Chhattisgarh Dental College and Research Institute | Baxter Healthcare Corporation |
India,
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 |
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