A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Phase: NA
Conditions: Gingival Recession, Palate; Wound
Sponsor: University of Alabama at Birmingham

 
A Study to Measure Pain Perception Following De-
Epithelized Free Gingival Graft Harvesting. 
 
 
 
Study Protocol & Statistical Analysis Plan 
 
 
NCT03895476 
 
January 23, 2023 
 
 
 
Hussein Basma, DDS, MS, Principal Investigator 
 
University of Alabama at Birmingham 
Birmingham, Al 35294 
 

 A Study to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting. 
 
05/06/2020 
 
1. Study Protocol 1. Objectives/Specific Aims:  
The purpose of this study is to compare the effect of a hemostatic collagen sponge, a collagen sponge sealed with a 
bio-adhesive material, a Platelet rich fibrin and a physical barrier(stent) on the palatal donor sites with the purpose 
of minimizing postoperative pain after epithelialized gingival graft harvesting. 
 
2. Materials and Method: 
Study population: 
A total of 80 patients seeking treatment at the UAB SOD Graduate Periodontology clinics will be recruited to 
participate in this study. The potential candidates will be approached during the treatment planning and/or pre-
surgical visit in the periodontal clinic. The investigator/research staff will give the information sheet to the potential 
participants, explain the study and obtain the patient demographics if the patient participate in the study. 
Conventional oral impressions will be made to fabricate a customized acrylic stent for the patient who will receive 
palatal stent.  
This study will conduct a survey using the (VAS) Visual Analog Scale of the postoperative pain following the (FGG) 
Free Gingival Graft procedure technique with four different methods for coverage of the palatal donor site and 
evaluating differences in the patient painkiller consumption and willingness to repeat the surgery in the future. On 
the day of the surgical procedure participants will be given copies of a pain survey (Visual Analog Scale) to be filled 
every day for two weeks (14 days). The participants will receive a reminder phone call daily to complete the survey. 
The completed survey (VAS) forms will be collected/returned to the research staff on the day of their follow-up visit.  
Study Group: 
1: Collagen Plug + Sutures (CPS)  
2: Collagen Plug with cyano-acrylate (CPC)  
3: Platelet-rich Fibrin (PRF) + sutures 
4: Palatal Stent (PS) 
 
3. Study Background: 
Periodontal plastic surgery has long been successfully performed for the treatment of gingival recessions and 
mucogingival deformities. Numerous techniques have been proposed in an attempt to obtain predictable root 
coverage outcomes. However, the results do not only depend on the technique selected but also on a variety of 
factors including but not limited to patient- and site-related factors.  
 
Harris in 1997 developed a technique based on a special scalpel for including an epithelial margin into the harvested 
CTG. Years later, several variations for CTG harvesting were described aiming at reducing the postoperative 
morbidity by ensuring healing by primary intention. However, these techniques required a certain amount of palatal 
thickness in order to avoid desquamation of the undermined superficial flap due to compromised vascularization. 
Indeed, as highlighted by Zucchelli and colleagues, a common complication of these harvesting techniques is the 

dehiscence or the necrosis of the primary flap if it was too thin or if sutures failed to secure it over the palatal 
wound.  
 
To avoid the necrosis of the primary flap, a certain amount of the sub-epithelial connective tissue should be 
preserved and because of this, the deeper connective tissue harvested is less dense, less stable, richer in fatty and 
glandular tissue, and more prone to shrinkage. Some clinical studies have reported higher postoperative pain and 
morbidity following EGG when compared to CTG. Hence, several attempts were undertaken to control the palatal 
pain following EGG harvesting techniques, such as irradiating the palatal wound using lasers, the addition of 
platelet-rich fibrin, or a collagen matrix over the donor wound site. These techniques reported different levels of 
success. Recently, bio-adhesive materials, such as cyanoacrylate surgical glue, have been successfully introduced in 
ophthalmology, in the treatment of massive hemoptysis, in embolization, and for wound closure in dermatology due 
to their strong sealing, bacteriostatic, and hemostatic properties. Among the advantages of bioadhesive materials, 
their high tissue compatibility and long half-life have also been described. 
 
This study will evaluate the postoperative pain following the EGG technique with four different methods for 
coverage of the palatal donor site. The control group will not be protected with any material. Test group 1 will be 
protected with Platelet rich Fibrin (PRF) while the test group 2 will consist of collagen protection with the additional 
layer of cyanoacrylate surgical glue. Test group 3 will consist of collagen protection with the application of a physical 
barrier (Stent) to cover the donor area.   
 
4. Statistical Analysis  
Patients’ demographics and clinic characteristics at baseline will be summarize with descriptive statistics such as 
mean, standard deviation (SD), frequency, and proportion where appropriate. The group comparisons at baseline 
will be conducted with analysis of variance (ANOVA) or Fisher’s exact test. Outcome variables – number of 
analgesics consumed and need for additional analgesics – will be summarize as median and range in each group and 
the group comparisons will be conducted with Kruskal-Wallis’s test followed by post hoc Bonferroni-corrected 
Wilcoxon rank-sum tests. All the other outcome variables including pain score, swelling level, amount of bleeding, 
activity tolerance, and the need for additional analgesics will be summarize with mean ± SD, and analyzed using a 
general linear mixed regression model to account for the repeated measures. Similar general linear mixed regression 
models will also use to explore the associations between outcome variables and graft length, width, area, and 
thickness. All analysis will be conducted using SAS 9.4 (Cary, NC, USA) under the significance level of 0.05. 
 
 
 

Visual Analog Scale (VAS)                                 Site: _______ 
Subject ID #: _______________                                                          Date: ____________ 
Please circle a number for each: 
1. Pain  
 
2. Swelling
 
0 
   1 
      2         3           4           5           6            7           8          9           10 
        No                                                      Moderate                                                    Severe 
     Swelling                                                  Swelling                                                   Swelling 
3. Bleeding
 
0 
   1 
      2         3           4           5           6            7           8          9           10 
         No                                                      Moderate                                                    Severe 
     Bruising                                                 Bruising                                                    Bruising 
4. Activity Tolerance Scale
 
0 
   1 
      2         3           4           5           6            7           8          9           10 
 
No                   Can              Interferes         Interferes          Interferes           Bedrest 
     Limitation 
  be                    with                   with               with basic         Required 
                               Ignored              Tasks         Concentration         Needs   
 
5. Did you need to take more painkillers due to palatal pain? Total No. of pills: ___                       
 
     0        1          2 
  3           4           5           6            7           8          9          10 
  No I didn’t need any         I took some     I almost finished them.  I needed them badly        
6. Will you do this surgery again?
 
0 
   1 
      2         3           4           5           6            7           8          9          10 
OMG,Definitely Not                           If I need to                               I Dont mind