NCT07856524

Brief Summary

This randomized clinical study compares sutureless wound closure using n-butyl-2-cyanoacrylate tissue adhesive with conventional silk suturing following minor oral surgical procedures. The study evaluates wound healing as the primary outcome, along with postoperative pain, time to hemostasis, closure time, intraoperative blood loss, and postoperative complications. Eighty patients were randomly allocated in a 1:1 ratio to either sutureless closure or conventional suturing and were followed for 14 days after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

Oral SurgeryPostoperative painSilk suturesWound healing

Outcome Measures

Primary Outcomes (1)

  • Wound Healing Score

    Wound healing assessed using the Landry, Turnbull, and Howley Healing Index, with scores ranging from 1 (very poor healing) to 5 (excellent healing).

    Postoperative Days 1, 3, 7, and 14

Study Arms (2)

Sutureless Closure

EXPERIMENTAL

Participants underwent sutureless wound closure using n-butyl-2-cyanoacrylate tissue adhesive (Histoacryl®) following minor oral surgical procedures. The wound margins were manually approximated, and a thin layer of tissue adhesive was applied along the approximated margins.

Procedure: Sutureless Wound Closure Using n-Butyl-2-Cyanoacrylate

Conventional Suturing

ACTIVE COMPARATOR

Participants underwent conventional wound closure using 3-0 black braided silk sutures placed in an interrupted pattern following minor oral surgical procedures. Sutures were removed on postoperative Day 7.

Procedure: Conventional Suturing

Interventions

The study protocol describes the intervention as n-butyl-2-cyanoacrylate tissue adhesive (Histoacryl) used for sutureless wound closure.

Also known as: n-Butyl-2-Cyanoacrylate, Histoacryl®, Cyanoacrylate Tissue Adhesive
Sutureless Closure

The study uses interrupted 3-0 black braided silk sutures, which are removed on postoperative day 7.

Also known as: 3-0 Black Braided Silk Sutures
Conventional Suturing

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18 to 45 years.
  • Classified as ASA physical status I or II.
  • Indicated for minor oral surgical procedures, such as impacted mandibular third molar removal, alveoloplasty, or periapical surgery.
  • Presence of healthy surrounding soft tissues at the surgical site.
  • Willingness to participate and provide written informed consent.
  • Ability to comply with postoperative follow-up visits.

You may not qualify if:

  • Systemic diseases known to impair wound healing, including uncontrolled diabetes mellitus, immunocompromised states, autoimmune disorders, and chronic renal or hepatic disease.
  • Bleeding disorders or use of anticoagulant/antiplatelet therapy.
  • Chronic corticosteroid or immunosuppressive therapy.
  • Active local infection at the surgical site.
  • History of smoking or smokeless tobacco use within the past 6 months.
  • Pregnant or lactating women.
  • Known hypersensitivity to cyanoacrylate or suture materials.
  • Poor oral hygiene, defined clinically by visible plaque accumulation and gingival inflammation.
  • Patients requiring bone grafting, membrane placement, or complex flap designs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Specialist Hospital

Sakakah, Al Jawf Region, 72345, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Enbucrilate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyanoacrylatesAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and Agriculture

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
Dr.

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

February 1, 2026

Primary Completion

May 28, 2026

Study Completion

May 31, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations