Cyanoacrylate With or Without Suture?

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083259
• Other study ID #: Palatal Wound Healing
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: April 5, 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: Gencay Keceli, PHD
• Phone: +90 312 305 2217
• Email: monsieur_gencay[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

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)

Procedure:
• Gelatin sponge stabilization with cyanoacrylate
Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test 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	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
Primary	Secondary bleeding time	Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).	during first week
Secondary	Graft height	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)	during surgery
Secondary	Graft width	Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm)	during surgery
Secondary	Graft thickness	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)	during surgery
Secondary	Working time	Harvesting process will be recorded by an blinded research assistant	during surgery
Secondary	Quantity of analgesics	Patients recorded the quantity of analgesics taken will be reported as quantity of pill	first week
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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