Tissue Adhesive Versus Sutures in Oral Biopsy Closure

NCT07654166 | Recruiting

• 1 other identifier: DN- 230226-649
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Excisional biopsies are commonly performed in the oral mucosa, and proper wound closure and hemostasis are critical for the success of the surgical procedure. Suturing remains the gold standard for closing surgical incisions; however, it has several drawbacks, including being time-consuming and requiring technical skill for proper placement. In addition, access to posterior areas of the oral cavity can be challenging. Suturing may also cause patient discomfort during needle penetration of tissues and can serve as a potential pathway for microbial contamination. Therefore, this randomized controlled clinical trial aims to evaluate one of the latest tissue adhesives from the cyanoacrylate group (PeriAcryl 90 HV) compared to conventional surgical sutures (Nylon 4-0) for wound closure following oral excisional biopsies. A total of 28 patients with oral fibroma will be randomly assigned to either the tissue adhesive group or the suture group (14 patients per group).

Conditions

Mouth Neoplasms

Keywords

PeriAcryl 90 HV; Oral fibroma; surgical sutures; excisional biopsy; tissue adhesive

Outcome Measures

Primary Outcomes (2)

• Early Wound Healing Score (EHS)

  Wound healing will be assessed using the Early Wound Healing Score (EHS), a validated clinical index that evaluates three parameters: clinical signs of re-epithelialization (CSR, scored 0-6), clinical signs of haemostasis (CSH, scored 0-2), and clinical signs of inflammation (CSI, scored 0-2). The total score ranges from 0 (worst healing) to 10 (excellent healing).

  Assessed at day 7 and day 14 postoperatively.

• Operative time (minutes)

  The time measured from the start of wound closure (immediately after excisional biopsy and hemostasis) to the complete wound closure. For the tissue adhesive group, this ends when the second layer polymerizes. For the suture group, this ends after the last interrupted suture is placed.

  Measured intraoperatively using a stopwatch.

Secondary Outcomes (1)

• Postoperative pain measured by Visual Analogue Scale (VAS)

  Measured at 24 hours, 3 days, and 7 days postoperatively.

Study Arms (2)

Tissue adhesive(PeriAcryl90 HV)

EXPERIMENTAL

Tissue adhesive (PeriAcryl 90 HV) will be applied directly to the wound surface after excisional biopsy.

Device: Tissue adhesive (PeriAcryl 90 HV)

Surgical sutures(Nylon 4-0)

ACTIVE COMPARATOR

Surgical suture (Nylon 4-0) will be used to close the wound with interrupted stitches.

Device: Surgical suture (Nylon 4-0)

Interventions

Tissue adhesive (PeriAcryl 90 HV) DEVICE

After excisional biopsy of oral fibroma and achieving hemostasis by applying pressure with saline-soaked gauze, the wound surface will be gently dried. PeriAcryl 90 HV (high viscosity butyl cyanoacrylate) will be applied directly using a pipette to cover the entire wound surface . A second layer will be applied 10-15 seconds after the first layer to ensure adequate thickness and durability. The adhesive will polymerize upon contact with moist tissue within approximately 10-20 seconds.

Tissue adhesive(PeriAcryl90 HV)

Surgical suture (Nylon 4-0) DEVICE

After excisional biopsy of oral fibroma and achieving hemostasis, the wound margins will be approximated using tissue forceps. Interrupted sutures using Nylon 4-0 will be placed to close the wound. Sutures will be removed on day 7 postoperatively.

Surgical sutures(Nylon 4-0)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University ,Department of Oral Medicine, Faculty of Dentistry

Damascus, Mazzh, Syria

RECRUITING

Related Publications (8)

• Gogulanathan M, Elavenil P, Gnanam A, Raja VB. Evaluation of fibrin sealant as a wound closure agent in mandibular third molar surgery--a prospective, randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2015 Jul;44(7):871-5. doi: 10.1016/j.ijom.2015.02.001. Epub 2015 Feb 23.

  PMID: 25721919 BACKGROUND

• Medeiros I, Pascoal S, Castro F, Macedo JP, Lopes O, Pereira J. Tissue adhesives for closure of intraoral surgical incisions: A systematic review and meta-analysis. Int Wound J. 2024 Oct;21(10):e70047. doi: 10.1111/iwj.70047.

  PMID: 39376068 BACKGROUND

• Oladega AA, James O, Adeyemo WL. Cyanoacrylate tissue adhesive or silk suture for closure of surgical wound following removal of an impacted mandibular third molar: A randomized controlled study. J Craniomaxillofac Surg. 2019 Jan;47(1):93-98. doi: 10.1016/j.jcms.2018.10.018. Epub 2018 Nov 12.

  PMID: 30501926 BACKGROUND

• Marini L, Rojas MA, Sahrmann P, Aghazada R, Pilloni A. Early Wound Healing Score: a system to evaluate the early healing of periodontal soft tissue wounds. J Periodontal Implant Sci. 2018 Oct 24;48(5):274-283. doi: 10.5051/jpis.2018.48.5.274. eCollection 2018 Oct.

  PMID: 30405935 BACKGROUND

• Suthar P, Shah S, Waknis P, Limaye G, Saha A, Sathe P. Comparing intra-oral wound healing after alveoloplasty using silk sutures and n-butyl-2-cyanoacrylate. J Korean Assoc Oral Maxillofac Surg. 2020 Feb;46(1):28-35. doi: 10.5125/jkaoms.2020.46.1.28. Epub 2020 Feb 26.

  PMID: 32158678 BACKGROUND

• Rezende ML, Cunha Pde O, Damante CA, Santana AC, Greghi SL, Zangrando MS. Cyanoacrylate Adhesive as an Alternative Tool for Membrane Fixation in Guided Tissue Regeneration. J Contemp Dent Pract. 2015 Jun 1;16(6):512-8. doi: 10.5005/jp-journals-10024-1714.

  PMID: 26323456 BACKGROUND

• Akhter J, Kalita S, Goyal R, Jaiswal P, Ramalingam K, Yadav D. A Comparison Between the Effectiveness of Isoamyl 2-Cyanoacrylate Tissue Adhesive and Silk Sutures in Wound Closure Following Minor Oral Surgical Procedures: A Prospective Clinical Study. Cureus. 2023 Jul 16;15(7):e41973. doi: 10.7759/cureus.41973. eCollection 2023 Jul.

  PMID: 37593271 BACKGROUND

• Ludlow JB, Kutcher MJ, Samuelson A. Intraoral digital imaging documenting recurrent aphthous ulcer healing in 2-octyl cyanoacrylate versus sham-treated lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Apr;89(4):425-31. doi: 10.1016/s1079-2104(00)70123-5.

  PMID: 10760725 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Tissue Adhesives; Sutures

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Nour J Ibrahim, DDS _ MSc student

CONTACT

+963959800513; nouribrahim649@gmail.com

Omar H Hamadah, Professor

CONTACT

+963940705554; Omar.hamadah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of oral medicine

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)