Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2012/05/002628 | Registry Identifier | Clinical Trials Registry - India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Sealant | Experimental | One quadrant surgically elevated will be closed with fibrin sealant |
|
| Suture | Placebo Comparator | The surgically elevated flap is closed with non resorbable sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant | Drug | Fibrin Sealant 4ml (Baxter Tisseel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of cytokines. | Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical inflammation | Gingival inflammation will be assessed at a clinical level. | 7, 14 and 21 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shaju P Jacob, MDS | Chhattisgarh Dental College and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chhattisgarh Dental College and Research Institute | Rāj-Nāndgaon | Chhattisgarh | 491441 | India |
Not provided
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D013537 | Sutures |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Suture | Drug | Black silk 000 |
|
|
| D053831 |
| Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |