Clinical trial · Interventional
Tissue Adhesive Versus Sutures in Oral Biopsy Closure
Comparison of Tissue Adhesive and Surgical Sutures for Wound Closure After Oral Excisional Biopsies: A Randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical suture (Nylon 4-0) | Device | — | UNRESOLVED |
| Tissue adhesive (PeriAcryl 90 HV) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tissue adhesive(PeriAcryl90 HV)
- description
- Tissue adhesive (PeriAcryl 90 HV) will be applied directly to the wound surface after excisional biopsy.
- interventionNames
- Device: Tissue adhesive (PeriAcryl 90 HV)
- type
- ACTIVE_COMPARATOR
- label
- Surgical sutures(Nylon 4-0)
- description
- Surgical suture (Nylon 4-0) will be used to close the wound with interrupted stitches.
- interventionNames
- Device: Surgical suture (Nylon 4-0)
Primary outcomes (2)
- measure
- Early Wound Healing Score (EHS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDGogulanathan 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
- BACKGROUNDMedeiros 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
- BACKGROUNDOladega 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
- BACKGROUNDMarini 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
- BACKGROUNDSuthar 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
- BACKGROUNDRezende 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
- BACKGROUNDAkhter 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.