AUTOLOGOUS FIBRIN GLUE VERSES 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE

EVALUATION AND COMPARISON OF THE EFFICACY OF AUTOLOGOUS FIBRIN GLUE WITH 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE AND WOUND HEALING - A SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL.

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 :

• 10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into sodium citrate vials and will be centrifuged for 30 min at 1200 g to obtain platelet-poor plasma (PPP).
• To the solution, fibrinogen and protamine sulphate will be added and will be centrifuged at 1000 g for 5 min to sediment the precipitate and fibrin glue will be procured.

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:

1. Mann-Whitney test
2. Wilcoxon signed rank test.

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Periodontal Flap Surgery; Other: Autologous fibrin glue; Other: 4-0 silk suture

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Neha Pradhan, BDS, Post graduate student; Phone Number: +91 9620508212; Email: pradhanneha92@yahoo.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with periodontitis, 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 (stage 3 periodontitis as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Condition and published by the American Academy of Periodontology) in at least two quadrants will be selected.

Exclusion Criteria:

• Patients who have undergone periodontal therapy during the previous 6 months, or exhibit poor plaque control after phase I therapy.
• History of any systemic disease such as diabetes mellitus, hypertension,osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
• Patients on drugs like aspirin, blood thinners and anticoagulant therapy
• Patients with history of allergy
• Current or former smokers.
• Mobility of selected teeth.
• Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous fibrin glue; 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.	Procedure: Periodontal Flap Surgery; Periodontal access flap surgery will be performed in both test site followed by control site in each subject; Other: Autologous fibrin glue; Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery
Active Comparator: 4-0 silk suture; The periodontal flap will be approximated using 4-0 black silk suture.	Procedure: Periodontal Flap Surgery; Periodontal access flap surgery will be performed in both test site followed by control site in each subject; Other: 4-0 silk suture; Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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; = Mild inflammation, slight change in color, slight edema, no bleeding on probing.; = Moderate inflammation, redness, edema, and glazing, bleeding on probing.; = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. 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

Collaborators and Investigators

• Sponsor: KLE Society's Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: nehafibringlue

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No