The Influence of Tissue Adhesive to Palatal Donor Site Healing.

Study Overview
=================
Brief Summary
-----------------
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. Patients recorded the quantity of analgesics (QA) taken, presence of secondary bleeding (SB) and pain perception (PP) daily for first postoperative week. Sensation loss (SL), color match (CM), epithelization level (EL) were evaluated at days 7, 14, 21 and 28.

Official Title
-----------------
The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial

Conditions
-----------------
Donor Site Complication

Intervention / Treatment
-----------------
* Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]
* Drug: Cyanoacrylate, Isobutyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18; PPS indication that needs CTG in anterior mandible; stable periodontium after phase I therapy; full-mouth plaque and bleeding scores <15% Exclusion Criteria: previous palatal harvesting history; unstable endodontic conditions; tooth mobility at surgical site; systemic disease; pregnancy; use of medications with potential adverse effects to periodontal tissues

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gelatine Sponge<br>After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) | Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]<br>* Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)<br>|
| Active Comparator: Gelatine sponge +Cyanoacrylate<br>After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group) | Drug: Cyanoacrylate, Isobutyl<br>* Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor site pain perception (PP) | Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain) | first week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary bleeding time (PBT) | Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT). | during surgery | 
| Graft height (GH) | Dimensions were measured with periodontal probe | during surgery | 
| Graft width (GW) | Dimensions were measured with periodontal probe | during surgery | 
| Graft thickness (GT) | Dimensions were measured with periodontal probe | during surgery | 
| Working time (WT) | Harvesting process was recorded | during surgery | 
| Quantity of analgesics (QA) | Patients recorded the quantity of analgesics (QA) taken | first week | 
| Secondary bleeding (SB) | Patients recorded presence/absence of secondary bleeding (SB) (yes or no). | first week | 
| Sensation loss (SL) | Sensation loss (SL) was scored as none, medium or severe | first week, second week , third week, fourth week. | 
| Color match (CM) | Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony) | first week, second week, third week, fourth week. | 
| Epithelization level (EL) | Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery | first week, second week, third week, fourth week. |