Cyanoacrylate With or Without Suture?

Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: Gelatin sponge stabilization with suture and cyanoacrylate; Procedure: Gelatin sponge stabilization with cyanoacrylate

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Inclusion Criteria:

• age ≥18;
• mucogingival surgical treatment indication that needs connective tissue graft in the 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 the surgical site;
• systemic disease;
• pregnancy;
• use of medications with potential adverse effects on periodontal tissues

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: gelatin sponge + cyanoacrylate + suspending sutures; After administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures.	Device: Gelatin sponge stabilization with suture and cyanoacrylate; The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)
Active Comparator: gelatin sponge + cyanoacrylate; After local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge and cyanoacrylate without sutures.	Procedure: Gelatin sponge stabilization with cyanoacrylate; Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor site pain perception	Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)	everyday in first week
Secondary bleeding time	Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).	during first week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft height	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)	during surgery
Graft width	Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm)	during surgery
Graft thickness	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)	during surgery
Quantity of analgesics	Patients recorded the quantity of analgesics taken will be reported as quantity of pill	first week
Epithelization level	Epithelization level was scored by researcher as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.	first week, second week, third week, fourth week.
The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.	The questionnaire has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health	first week
Working time	Harvesting process will be recorded by an blinded research assistant	during surgery
Sensation loss	Sensation loss will be scored by the help of clinician comparing with the symmetrical side an will be recorded as no-loss, medium loss or severe loss	first week, second week , third week, fourth week.
Color match	Color match with the adjacent tissue was determined by researcher using a Visual Analog Pain Scale scale (0: absence of harmony, 10: excellent harmony)	first week, second week, third week, fourth week.

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): August 16, 2024
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Palatal Wound Healing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No