Cyanoacrylate With or Without Suture?

NCT06083259 | Completed

• 1 other identifier: Palatal Wound Healing
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Graft height

  during surgery

• Graft width

  during surgery

• Graft thickness

  during surgery

• Working time

  during surgery

• Quantity of analgesics

  first week

Study Arms (2)

gelatin sponge + cyanoacrylate + suspending sutures

ACTIVE COMPARATOR

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

gelatin sponge + cyanoacrylate

ACTIVE COMPARATOR

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

Interventions

Gelatin sponge stabilization with suture and cyanoacrylate DEVICE

The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)

gelatin sponge + cyanoacrylate + suspending sutures

Gelatin sponge stabilization with cyanoacrylate PROCEDURE

Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)

gelatin sponge + cyanoacrylate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sutures; Cyanoacrylates

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 13, 2023
• Study Start: December 5, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)