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The study is a split mouth study but the interventions for the two different arms will be spaced by a fixed duration in time. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Following phase-1 periodontal therapy, randomisation for the test and control quadrants will be done. Surgical debridement will be done first for the control side to avoid the carry-across effect of fibrin glue. Control and test procedures will be performed with a wash out period of 15days.
Preparation of Autologous fibrin glue :
Prior to commencement of periodontal flap surgery GCF collection will be done. Following anaesthesia and elevation of full thickness muco periosteal flap, thorough debridement and root planning of the exposed root surfaces will be done. On the control site, the periodontal flap will be approximated using 4-0 black silk suture. Patients will be instructed to rinse twice daily with 0.12% chlorhexidine and recalled after 7 days for suture removal and post-surgical GCF collection from the control side. After a wash out period of 15 days presurgical GCF sampling along with the surgical procedure will be performed on the test side. The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. Persistence of bleeding, stability of tissues 5 minutes after repositioning will be recorded and the amount of fibrin sealant used in the procedure will be determined.Patients will be then recalled after 7 days for evaluation and post-surgical GCF collection from the test site. Clinical parameters will be assessed at 7, 14, 21 and 28 days.
Collection of GCF :
GCF will be collected immediately prior to surgery and on seventh day following surgery from both test and control sites for wound healing assessment. Samples of GCF will be collected from four sites from the surgical site following isolation. Colour - coded, 1-5 microlitre calibrated volumetric micro capillary pipettes will be kept extra-crevicularly for not more than five minutes or until 1 microlitre is collected. The fluid will be immediately transferred to a plastic vial and frozen at -20 degree Celsius for further analysis. Pipettes in sites which do not express any fluid or those contaminated with blood/saliva will be discarded.
Statistical analysis:
The data gathered from the study will be subjected to appropriate statistical analysis. The statistical analysis will be done using:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous fibrin glue | Experimental | The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. |
|
| 4-0 silk suture | Active Comparator | The periodontal flap will be approximated using 4-0 black silk suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal Flap Surgery | Procedure | Periodontal access flap surgery will be performed in both test site followed by control site in each subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine parameter | Interleukin 1-β will be assessed in GCF using a commercially available Enzyme-linked immunosorbent assay kit (ELISA), specific for human IL-1 β | Change from baseline to 7days |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Hygiene Index | by John C Greene & Jack Vermilion in 1964 OHI = DI + CI INTERPRETATION Good 0.0-1.2 Fair 1.3-3.0 Poor 3.1-6.0 | Changes from baseline to 7day, 14day, 21day, 28day |
| Early Wound Healing Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neha Pradhan, BDS, Post graduate student | Contact | 9620508212 | +91 | pradhanneha92@yahoo.in |
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For the purpose of confidentiality as will be promised to the participants while signing the informed consent , all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Patients diagnosed with periodontitis, in the age group of 18 to 60 years with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm
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The study design follows a double blinded design where the investigator and the outcome assessor are unaware of the intervention to the subject
| Autologous fibrin glue | Other | Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery |
|
| 4-0 silk suture | Other | Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery |
|
Index given by Watchel et al in 2005
SCORING CRITERIA:
DEGREE 1-Complete flap closure No fibrin line in the interproximal area DEGREE 2- Complete flap closure Fine fibrin line in the interproximal area DEGREE 3- Complete flap closure Fibrin clot in the interproximal area DEGREE 4- Incomplete flap closure Partial necrosis of interproximal tissue DEGREE 5- Incomplete flap closure Complete necrosis of interproximal tissue
| Changes from baseline to 7th day, 14th day, 21st day and 28th day |
| Gingival Index | Index given by Loe and Silness in 1963 Scoring criteria 0 = Normal gingiva
Score 0.1-1.0-Mild gingivitis 1.1-2-Moderate gingivitis 2.1-3.0 Severe gingivitis | Changes from baseline to 7th day, 14th day, 21st day and 28th day |
| VAS score | Index given by Freyd in 1923 Scale -1-10 Score Scale: 0-10 Score 0-No pain 1-3: Mild 4-6: Moderate 7-9: severe 10-worst | Changes from baseline to 7th day, 14th day, 21st day and 28th day |