Tissue Adhesive Versus Sutures in Oral Biopsy Closure

Appropriate closure of the surgical wound is essential for achieving successful surgical outcomes and optimal wound healing. Although sutures are the most commonly used method for closing wounds in the oral mucosa, they may cause discomfort to patients, particularly in the buccal and labial mucosa. Furthermore, sutures require a second clinical visit for removal. These limitations highlight the clinical need for an alternative to conventional sutures that is easy to apply, does not require removal, and minimizes patient discomfort. This study will compare tissue adhesive (PeriAcryl 90 HV) versus surgical sutures (Nylon 4-0) for wound closure after oral fibroma excision in a randomized controlled trial design.

• 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.
• 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.

Primary outcomes

• Early Wound Healing Score (EHS) [Assessed at day 7 and day 14 postoperatively.]: 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).
• Operative time (minutes) [Measured intraoperatively using a stopwatch.]: 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.

Secondary outcomes

• Postoperative pain measured by Visual Analogue Scale (VAS) [Measured at 24 hours, 3 days, and 7 days postoperatively.]: Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), where 0 cm represents "no pain" and 10 cm represents "the worst possible pain". Patients will be asked to mark their pain level on the scale at each time point.

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

-Patients clinically diagnosed with oral fibroma located on the

labial mucosa (lip) or buccal mucosa (cheek).

* Lesion requires excisional biopsy.
* Lesion size greater than 3 mm and less than 3 cm in

greatest diameter.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients taking anticoagulant medications (blood thinners).
* Patients with infectious diseases such as hepatitis, HIV, etc.
* Patients taking immunosuppressants.
* Patients with uncontrolled diabetes mellitus.
* Patients taking medications that affect bleeding and wound healing.

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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