Effect of Fibrin Sealant on Early Wound Healing (FS)
This study has been completed.
Sponsor:
Chhattisgarh Dental College and Research Institute
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute
ClinicalTrials.gov Identifier:
NCT01538927
First received: February 10, 2012
Last updated: December 22, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Periodontitis |
Drug: Fibrin Sealant Drug: Suture |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial. |
Further study details as provided by Chhattisgarh Dental College and Research Institute:
Primary Outcome Measures:
- Concentration of cytokines. [ Time Frame: 7 days ] [ Designated as safety issue: No ]Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
Secondary Outcome Measures:
- Clinical inflammation [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]Gingival inflammation will be assessed at a clinical level.
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fibrin Sealant
One quadrant surgically elevated will be closed with fibrin sealant
|
Drug: Fibrin Sealant
Fibrin Sealant 4ml (Baxter Tisseel)
Other Name: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
|
|
Placebo Comparator: Suture
The surgically elevated flap is closed with non resorbable sutures.
|
Drug: Suture
Black silk 000
Other Name: Ethicon
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A subject has to be between the ages of 18 and 60 years.
- 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.
- Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
- Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
- Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
- Endodontic status: Teeth had to be vital or properly treated with root canal therapy
Exclusion Criteria:
- History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Current or former smokers.
- Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
- Mobility of selected teeth.
- Pregnant or lactating women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538927
Locations
| India | |
| Chhattisgarh Dental College and Research Institute | |
| Raj Nandgaon, Chhattisgarh, India, 491441 | |
Sponsors and Collaborators
Chhattisgarh Dental College and Research Institute
Baxter Healthcare Corporation
Investigators
| Principal Investigator: | Shaju P Jacob, MDS | Chhattisgarh Dental College and Research Institute |
More Information
No publications provided
| Responsible Party: | Dr Shaju Jacob P, Professor, Chhattisgarh Dental College and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01538927 History of Changes |
| Other Study ID Numbers: | CDC0212-FS, CTRI/2012/05/002628 |
| Study First Received: | February 10, 2012 |
| Last Updated: | December 22, 2012 |
| Health Authority: | India: Institutional Review Board, Board of Research on Humans |
Keywords provided by Chhattisgarh Dental College and Research Institute:
|
fibrin sealant tissue adhesive wound healing interleukin 1 beta interleukin 8 |
Additional relevant MeSH terms:
|
Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases Fibrin Tissue Adhesive |
Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013