To evaluate the efficacy of the GPCS for palatal hemostasis during and after the FGG harvesting procedure.
A secondary objective was to evaluate if the placement of the suture improved the operator
visibility thereby reducing the surgical time.
2. PALATAL PRE-SUTURING FOR
PERIOPERATIVE HEMOSTASIS AT
FREE GINGIVAL GRAFT DONOR
SITES—A RANDOMIZED
CONTROLLED CLINICAL TRIAL
Mihir Raghavendra Kulkarni, Leena Gangadhar Shettar, Purva Vijay
Bakshi, Kriti Nikhil
Dr. Beena Vijayan Parvathy
Post graduate
Department of Periodontics
JAN 2021
3. INTRODUCTION
•The palatal free gingival graft (FGG) and subepithelial connective tissue graft (SCTG)
are commonly used soft tissue grafts for periodontal and peri-implant soft tissue
augmentation.
• The autogenous palatal grafts are known for their excellent clinical performance in aspects of
integration of the graft at the recipient site, improvement of tissue biotype and the augmentation
of the width of keratinized gingiva.
• Palatal soft tissue grafts, it is often necessary to operate in an area that is in close proximity to
the greater palatine vascular bundle (GPB).
• Excessive hemorrhage from the palatal donor site due to injury to the GPB is a recognized
complication associated with palatal tissue harvesting.
Griffin TJ et al, 2006
4. • Hemorrhage during or after the palatal tissue harvesting procedure creates multiple concerns for
the operator as well as the patient:
For the operator, the visibility of the surgical field is hampered and consequently the surgical
time is prolonged.
For the patient, a hemorrhagic episode may lead to anxiety and a negative perception of the
treatment protocol, perhaps discouraging the patient from seeking similar treatment in the future.
•Several methods have been described in literature to manage hemorrhage from the palatal soft
tissue donor site and/or support its healing:
Use of local hemostatic agents
Ligature wires
Periodontal dressings
Modified Hawley’s appliance
Platelet-rich fibrin (PRF)
5. •Suturing of the GPB or terminal vascular branches is a popular and effective technique to control
the palatal hemorrhage.
• An elaborate protocol to place a greater palatine compression suture (GPCS) was reported to
be a predictable method to control palatal hemorrhage. Kulkarni MR et al, 2018
6. To evaluate the efficacy of the GPCS for palatal hemostasis during and after the FGG harvesting
procedure.
A secondary objective was to evaluate if the placement of the suture improved the operator
visibility thereby reducing the surgical time.
Aim & objectives
7. MATERIALS AND METHODS
•The study was a prospective, randomized controlled clinical trial with a parallel-arm design to
evaluate the hemostatic potential of the GPCS.
Study population
•The participants consisted of 24 patients (14 females and 10 males) in the age group of 18 to 50
years.
•The participants required an FGG for the treatment of gingival recession or augmentation of the
width of attached gingiva.
8. Inclusion Criteria
1. No systemic disorder affecting the coagulation of blood.
2. No systemic factors such as hypertension, diabetes mellitus, pregnancy, or lactation.
3. No environmental factors like smoking or tobacco chewing.
4. No history of use of anti-coagulant or anti-platelet medication.
5. Presence of a gingival recession or mucogingival problem that requires a FGG.
Exclusion Criteria
1. Patients requiring additional hemostatic measures to control palatal hemorrhage post-
surgically.
9. Sample size and Randomization
•A pilot study was performed with 10 participants randomly assigned to the two groups. Based on
the results of the pilot study, the sample size was calculated.
•A minimum of 12 patients was required.
•Considering the availability of patients and the intended duration of the study, 12 participants
per group were recruited.
•A total of 28 patients were screened for participation in the study of whom, two patients declined
to participate, and two patients were excluded as they had a history of use of aspirin as an anti-
platelet medication.
10.
11. • The procedures of randomization and palatal suture placement were done by different
investigators, but the investigator who placed the palatal suture also analyzed the blood loss. No
blinding was incorporated in the study design.
Surgical protocol
• The palate was anesthetized using 0.5 mL of 2% lignocaine solution with 1:200,000 adrenaline
In both groups.
• A greater palatine nerve block technique was used for the palatal anesthesia.
• The procedure of placement of the GPCS was done by a single operator. In the test group
(group 1), the palate was anesthetized and the GPCS was placed.
• The FGG harvesting was done.
• In the control group (group 2), the palate was anesthetized and the FGG was harvested without
any pre-suturing.
12. • The midline of the palate was identified (Line Y) and an imaginary line perpendicular to the
midline was projected between the first and second molars (Line X).
• A point "A" was identified on line X, about 20 mm from the palatal midline.
• A 20-mm triangular, half - circle needle with a 3‒0 black braided silk suture was passed along
its curve to the depth of the palatal vault from point A toward the palatal mid-line.
• The point of emergence (point B) of the needle was about 10-mm medial and about 5-mm
anterior to point A.
• The suture was then secured with a surgeon’s knot with enough tension to cause visible
blanching of the palate.
13.
14. • After placement of the GPCS in the test group, the FGG of required dimensions was obtained
by sharp dissection using a 15c Bard-Parker blade.
• A uniform graft thickness of between 1 and 1.5 mm was ensured in all the patients. The
obtained graft was then sutured at the recipient site for recession coverage or for the
augmentation of attached gingiva using polyglactin 910 sutures.
15. Measurement of blood loss
• An electronic (digital) weighing scale with sensitivity of 1g was used.
• Sterile cotton gauze was moistened by using 10 ml of sterile 0.9 g/L saline solution. The moist
sterile surgical cotton gauze was weighed before commencing the procedure.
• This cotton gauze was used to mop the blood oozing from the palatal FGG donor site until the
bleeding stopped and was stored separately.
• Use of suction to clear the palatal hemorrhage was strictly avoided to minimize errors in
measurement of blood loss.
• The soiled gauze was weighed along with any unused gauze after completion of the surgery.
16.
17. Measurement of duration of the surgery
• The total duration of the surgery was measured as the period from the time of anaesthetizing the
palate to the time of placement of periodontal dressing at the FGG recipient site.
Post-surgical protocols
• A non-eugenol periodontal dressing was used to cover the donor and recipient sites.
• The post-surgical medications included amoxicillin 500 mg + clavulanic acid 125 mg, 3 times a
day for a period of 5 days and ibuprofen 600 mg up to 3 times a day for a period of 4 days.
•A 0.12% chlorhexidine mouthwash was prescribed 2 times a day for a period of 2 weeks to
enable plaque control as a part of the routine protocols after soft tissue grafting procedures.
• The patients were recalled for after 1 week for examination and removal of palatal suture. The
dressing and sutures at the recipient site were removed after 2 weeks.
18. • The patients were evaluated at intervals of 7, 14, 21, and 30 days postoperatively. The healing
of the palatal donor site was assessed clinically at all the recall intervals.
• No objective method was used to analyze the healing of the palatal donor site.
20. • In the test group, the mean weight of the moistened gauze before the procedure was 19.9± 2.1g
and that in the control group was 18.7 ± 2.2 g.
• The difference between the weight of gauze before and after the surgery was 4.33 ± 0.89 g for
the test group and 8.91 ± 4.16 g for the control group.
• The mean surgical time required for the test group was 73.25 ± 22.35 minutes and that for the
control group was 76.08 ± 14.47 minutes.
21. • The main outcome measure was the amount of blood loss as measured by weighing the gauze,
and the secondary variable was the amount of time required for the surgery.
•The difference between the presurgical weight of the gauze in both the groups was statistically
in significant.
• The difference between the post-surgical weight of the gauze in both the groups was found to be
statistically significant with the post-surgical weight of the gauze in the test group being
significantly less than that in the control group.
• All statistical analyses were performed using software.
22. • A subjective assessment of the palatal healing by clinical examination did not reveal any
differences between the two groups, with all the participants showing complete palatal wound
healing at the 21 days recall visit.
• The patients did not report any pain or discomfort associated with the palatal suture.
• Incidence of postoperative bleeding and dislodgement of the palatal periodontal dressing was
reported by two patients in the control group on the same day of the surgery.
• None of the patients in the test group reported delayed bleeding from the palatal site.
• The healing of the graft at the recipient site was uneventful in all the patients with no incidence
of graft necrosis.
23. •Out of the 24 participants, 18 (10 in the test group and eight in the control group) were treated
for gingival recession with the mandibular anterior teeth.
• Mean recession coverage was noted at the 1-month recall visit.
• Mean recession coverage in the test group (n = 10) was 1.7 ± 0.95 mm and that in the control
group (n = 8) was 1.62 ± 0.92 mm.
24. DISCUSSION
• Most of the techniques described in the literature for the management of palatal hemorrhage are
used to control the bleeding once it has already occurred.
• Techniques often involved are the use of acrylic stents, ligature wires, and periodontal dressings
and have not been documented for their clinical efficacy in clinical trials.
Farnoush A et al, 1978
• The efficacy of oxidized regenerated cellulose, absorbable gelatin sponge and moistened gauze
for controlling the palatal hemorrhage after harvesting an FGG was compared. That resulted in a
faster palatal hemostasis in oxidized regenerated cellulose or absorbable gelatinas compared with
pressure alone. They also found that the healing of the palatal wound was delayed in the gelatin
sponge group.
Rossman et al and Rees et al, 1999
• PRF has been found to be effective in augmenting the healing of the palatal FGG donor site.
PRF has also been noted to exert a hemostatic effect on the palatal wound and has been suggested
to be of use in the homeostasis of oral wounds. Ozcan M et al, 2017
25. • Use of an adjunctive hemostatic aid often involves added surgical time and expense and this
may be precluded with the use of a “preventive” suture, if seen to be effective.
• Greenstein et al, 2008 have recommended that such a palatal suture be placed before beginning
the palatal graft harvesting to prevent hemorrhage.
• A precise protocol for the placement of the GPCS was suggested by Kulkarni et al, 2018. This
protocol was based on a predicted location of the greater palatine foramen and vascular bundle.
• Methods to measure the perioperative blood loss include direct volumetric estimation, weighing
of soiled gauze, use of various formulae based on hematocrit values, and visual estimation.
Withanathantrige M et al, 2016; Lopez-Picado A et al, 2017 & Brennan Y et al,2020
• In this study, the amount of lost blood was estimated by using the gauze weight method which
is a method to directly estimate the blood loss.
• This is the first clinical trial to objectively evaluate the efficacy of palatal pre-suturing to control
the perioperative hemorrhage from an FGG donor site.
26. CONCLUSIONS
Palatal pre-suturing by using the GPCS is an effective technique to reduce the perioperative
hemorrhage during the harvesting of an FGG. This technique does not require any special
material or devices and can be recommended for clinical use. Clinical trials using more accurate
methods of estimation of blood loss, will further contribute towards evaluating the clinical use
of this technique.
27.
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