The Influence of Tissue Adhesive to Palatal Donor Site Healing.

Donor Site Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403503
• Other study ID #: Cyanoacrylate
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Donor Site Complication

Intervention

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)
• 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).

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Graft height (GH)	Dimensions were measured with periodontal probe	during surgery
Secondary	Graft width (GW)	Dimensions were measured with periodontal probe	during surgery
Secondary	Graft thickness (GT)	Dimensions were measured with periodontal probe	during surgery
Secondary	Working time (WT)	Harvesting process was recorded	during surgery
Secondary	Quantity of analgesics (QA)	Patients recorded the quantity of analgesics (QA) taken	first week
Secondary	Secondary bleeding (SB)	Patients recorded presence/absence of secondary bleeding (SB) (yes or no).	first week
Secondary	Sensation loss (SL)	Sensation loss (SL) was scored as none, medium or severe	first week, second week , third week, fourth week.
Secondary	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.
Secondary	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.