Palatal Wound Healing Evaluation After Application of Platelet Rich Fibrin Versus 0.2% Hyaluronic Acid Dressings (Randomized Controlled Clinical Trial)
Phase: PHASE4
Conditions: Free Gingival Graft
Sponsor: Ain Shams University

Palatal Wound Healing Evaluation After 
Application of Platelet Rich Fibrin Versus 0.2% 
Hyaluronic Acid Dressings  
(Randomized Controlled Clinical Trial) 
 
Methodology 
 
Date: 12/5/2020 

                                                 Material and Method
 
 
 
 
 
Sample selection and assignment: 
Thirty patients (16 females and 14 males) who were 
candidates for free gingival grafting surgery participated in 
this prospective clinical trial. 
The subject were recruited consecutively from the 
outpatient clinic of Oral Medicine, Periodontology, oral 
Diagnosis and Radiology Department, Faculty of Dentistry, 
Ain Shams University .The purpose of the study was 
explained to all patients and an informed consent was 
signed before the conduction of the study.  The proposal 
was presented to the faculty of Dentistry Ain Shams 
University Research Ethics committee and was approved 
before starting the research with number (566). Also the 
study was registered in clinical trial registration site (NCT). 
 
Patient selection: 
Inclusion Criteria: 
 Patients who were indicated for soft tissue 
augmentation 
with 
free 
gingival 
graft 
for 
mucogingival surgery or for implant therapy. 

                                                 Material and Method
 
 
 
 
  Age range (20-50) years. 
  Good patient compliance with the plaque control 
instructions following initial therapy. 
Exclusion criteria: 
 Presence of systemic diseases which could 
influence 
the 
outcome 
of 
the 
therapy. 
(American Society of Anesthesiologists I; 
ASA I) 
 Smoker patients. 
 Pregnant and lactating females. 
 Vulnerable group of patients (prisoners, 
handicapped, 
decisionally 
impaired 
individuals). 
 
 
 
 
 
 

                                                 Material and Method
 
 
 
 
Grouping Criteria: 
The study consisted of three groups; the number of 
patient in each group was determined by sample size 
calculation based upon the results of Yildirim et al. 
2017. Using alpha level of 0.05 (5%) and β level of 
0.20 (20%) i.e. power = 80%; the estimated 
minimum required sample size was approximately 
10 cases in each group.  Patients were randomly 
selected using computer generated randomization 
(www.randomizer.org). Allocation concealment was 
achieved using a sealed coded opaque envelope 
containing treatment of the subject 
Group I(10 patients): 
Patients received platelet rich fibrin as a palatal 
dressing after free gingival graft harvesting. 
Group II(10 patients): 
Patients received hyaluronic acid* gel 3-4 times per 
day as a palatal dressing after free gingival graft 
harvesting. 
Group III(10 patients) (Control group) : 
Patients received gel foam as a palatal dressing after 
free gingival graft harvesting 
                                                                
 
*Gengiegel 0.2% oral gel 20ml Riceerfarma Milano Italy. 

                                                 Material and Method
 
 
 
 
III- Assessments: 
1-Clinical parameters: 
 Subjective assessment 
-Patients were asked to assess their pain sensation and 
bleeding at 1st, 3rd, 7th 14th, 21stand 30th days using the 
visual analogue scale (VAS). The visual analogue scale 
score by Price et al 1983 for pain ranged from 0 (no pain) 
to 10 (severe pain), while bleeding wasscored as 0(not 
present) and 1(present) (Price et al.1983). 
 Objective assessment 
-The Healing index scale by Landry et al.1988 was used to 
assess the palatal wound healing, where in this index tissue 
color, response to palpation, presence of granulation tissue 
presence of suppuration and epithelization of the incision 
margin were recorded. 
-The color of the palatal mucosa was assessed by 
comparing it to the adjacent and opposite side by taking 
pictures and using the image J program  at 3rd,7th, 14th, 21st 
and30th days ( Pei-Nan et al.2012). 
 
 
- The thickness of the palatal mucosa was measured 
preoperative and 4 weeks postoperative by a graduated 
periodontal probe. 

                                                 Material and Method
 
 
 
 
 
Fig (1): Palatal thickness measurements at 3 
different points the middle of 1st, 2nd premolar and 
1st molar 7mm from the gingival margin 
 
 
 
 
 
 
 
 
 
 
 
 

                                                 Material and Method
 
 
 
 
IV-Surgical protocol: 
A) Pre surgical procedures 
Scaling and root planning was done; oral hygiene 
instructions was given to the patient to follow them. 
B) Surgical procedures 
 Group 1: 
1. Anesthesia 
(Articaine 
HCL 
4% 
containing 
epinephrine at a concentration of 1:100,000)† was 
administrated at to the palate where a free gingival 
graft was harvested. 
2. Just prior to surgery a 10 ml intravenous blood was 
obtained from the median antecubital vein of the 
patient in order to be divided into two 5 ml glass 
tubes‡ 
without 
additives 
to 
be 
§centrifuged 
immediately at 2700 revolutions per minute for 12 
minutes or in one 10 ml glass test tube without 
additives were centrifuged immediately at 3000 
revolutions per minute for 10 minutes at room 
temperature. 
                                                                
 
†Artinibsa 4%cartouches de 1.8ml ,inibisa dental. 
‡ Dry Vacutube, Biocon®, Brazil 
§ PRF CENTRIFUGE (Duo machine), UNSPSC code 41100000 ( Ostralos Ltd, 
New Zealand ) 
 

                                                 Material and Method
 
 
 
 
3. Coagulation started immediately and three parts 
quickly appear in the tube: a packed red blood cell at 
the bottom, acellular plasma at top and the PRF clot 
in between. 
4. The PRF clot was removed from the tube using 
sterile tweezers, separating it from the RBC base by 
using a lancet.   It was compressed between two 
sterile glass slabs and wrapped within sterile gauze 
moistened with saline. 
5. The thickness of the palatal tissue was measured at 
three different points; each point was located at the 
middle of 1st, 2nd premolar and 1st molar 7mm from 
the gingival margin. 
6. Free gingival graft was harvested from the 
palateand its thickness was measured. 
7. The PRF membrane was placed as a palatal 
dressing and fixed in place by X suture using 5-0 
polypropylen**. 
 
 
 
                                                                
 
** Assut Sutures,  non Absorbabale (Polypropylene) 5-0 USP, braided violet coated 
3/8 rev.cutt.17mm, AM trading, Swithezland 

                                                 Material and Method
 
 
 
 
Group 2: 
1. Anesthesia 
(Articaine 
HCL 
4% 
containing 
epinephrine at a concentration of 1:100,000)†† was 
administrated at to the palate where a free gingival 
graft was harvested. 
2.  The thickness of the palatal tissue was measured at 
three different points; each point was located at the 
middle of 1st, 2nd premolar and 1st molar 7mm from 
the gingival margin. 
3. Free gingival graft was harvested from the palate 
and its thickness was measured. 
4. Gel foam was cut according to the graft’s 
dimensions to act as a carrier for the hyaluronic 
acid‡‡that was used as a palatal dressing. 
5.  Gel foam was fixed in place using X suture using 
§§5-0 polypropylene. 
 
 
 
 
 
                                                                
 
††Artinibsa 4%cartouches de 1.8ml ,inibisa dental. 
‡‡Gengiegel 0.2% oral gel 20ml Riceerfarma Milano Italy.
 
§§ Assut Sutures,  non Absorbabale (Polypropylene) 5-0 USP, braided violet coated 
3/8 rev.cutt.17mm, AM trading, Swithezland 

                                                 Material and Method
 
 
 
 
Group 3: 
1. Anesthesia 
(Articaine 
HCL 
4% 
containing 
epinephrine at a concentration of 1:100,000)*** was 
administrated at to the palate where a free gingival 
graft washarvested. 
2.  The thickness of the palatal tissue was measured at 
three different points; each point was located at the 
middle of 1st, 2nd premolar and 1st molar 7mm from 
the gingival margin. 
3. Free gingival graft was harvested from the palate 
and its thickness was measured. 
4. Gel foam was cut according to the graft’s 
dimensions and used as a palatal dressing. 
5.  Gel foam was fixed in place using X suture using 
5-0 polypropylene†††. 
 
 
 
 
 
                                                                
 
***Artinibsa 4%cartouches de 1.8ml ,inibisa dental. 
††† Assut Sutures,  non Absorbabale (Polypropylene) 5-0 USP, braided violet 
coated 3/8 rev.cutt.17mm, AM trading, Swithezland 

                                                 Material and Method
 
 
 
 
V-Postoperative care: 
 Oral hygiene instructions was given , antibiotic 
(Augmentin‡‡‡ 1 gm every 12 hours, metronidazole§§§ 
500 mg every 12 hours) , anti-inflammatory and 
analgesics( Brufen**** 400 every 12 hours)  was 
prescribed for the patient and instructed to avoid 
brushing at the surgical site only rinsing with hot saline 
mouthwash. 
 Patient was recalled for assessment and follow up, 
sutures was removed after 1 week. 
 
 
 
 
 
 
 
 
                                                                
 
‡‡‡ Augmentin 1gm,Medical union pharmaceuticals( MUP) Egypt under license 
from ,Glaxosmithkline
 
§§§Flagyl 500 mg, sanafi Aventis Egypt under license of sanafi Aventis French
 
****Brufen 400mg, Al kahira  pharm. and chem..Ind.Co. under license from abbott 
laboratories
 

                                                 Material and Method
 
 
 
 
 
VI-Postoperative evaluation and assessment: 
 Patients were asked to assess their pain sensation and 
bleeding at 1st, 3rd, 7th 14th, 21st and 30th days using 
the visual analogue scale (VAS). The visual analogue 
scale score by Price et al 1983 for pain ranged from 0 
(no pain) to 10 (sever pain), while bleeding was scored 
as 0(not present) and 1(present). 
 
 The Healing index scale by Landry et al. 1988 was used 
to assess the palatal wound healing, where in this index 
tissue color, response to palpation, presence of 
granulation 
tissue 
presence 
of 
suppuration 
and 
epithelization of the incision margin were recorded. 
 
 The color of the palatal mucosa was assessed by 
comparing it to the adjacent and opposite side by taking 
pictures and using the image J program   at 3rd,7th, 
14th, 21st and30th days. 
 
 
 The thickness of the palatal mucosa was measured 
preoperative and 4 weeks postoperative by a graduated 
periodontal probe. 
 
 

                                                 Material and Method
 
 
 
 
IV-Statistical analysis: 
 
Categorical data were presented as frequencies and 
percentages and were analyzed using chi square test. 
Numerical data were tested for normality using Shapiro-
Wilk test and were presented as mean and standard 
deviation values. Parametric data were analyzed using one-
way ANOVA followed by Tukey’s post hoc test for 
intergroup comparisons and one-way repeated measures 
ANOVA followed by Bonferroni post hoc test for 
intragroup 
comparisons. 
Non-parametric 
data 
were 
analyzed using Kruskal-wallis test followed by pairwise 
comparisons 
utilizing 
Mann 
Whitney 
U 
test 
with 
Bonferroni correction for intergroup comparisons and 
Friedman’s test of repeated measures followed by multiple 
pairwise comparisons utilizing Wilcoxon signed-rank test 
with Bonferroni correction for intragroup comparisons. The 
significance level was set at p ≤0.05 within all tests. 
Statistical analysis was performed with IBM® SPSS® 
Statistics Version 26 for Windows. 
 
                                                                
 
® IBM Corporation, NY, USA. 
®SPSS, Inc., an IBM Company.