The Influence of Tissue Adhesive to Palatal Donor Site Healing.

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

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.

Study Overview

• Status: Completed
• Conditions: Donor Site Complication
• Intervention / Treatment: Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]; Drug: Cyanoacrylate, Isobutyl

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gelatine Sponge; 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]; Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
Active Comparator: Gelatine sponge +Cyanoacrylate; 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; 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).

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.

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Thrombin; Gelatin Sponge, Absorbable
• Other Study ID Numbers: Cyanoacrylate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No