Periodontitis Clinical Trial
Official title:
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- 10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into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.
n/a
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