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Completed

NCT Number: NCT04898816

Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives.

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Key information

Conditions

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melaka Manipal Medical College

Melaka Tengah, Melaka, 75150, Malaysia

About this study

Conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. Suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. Patient has to come for a second visit for removal of suture. Moreover tight sutures may lead to ischemia and necrosis.

Tissue adhesives adopts the idea of sutureless wound closure. They are even sloughed off from the surface of mucosa 7 days after the application.

This study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients requiring surgical removal of mesioangular, position A impacted mandibular third molar
  • clean incisions approximately 2-3 cms in length which can be approximated
  • Healthy (ASAI) or patients with mild systemic disease no functional limitations
  • Patients not allergic to the drugs or anesthetic agents used in the surgical protocol

Exclusion criteria

  • Patients taking any medications that influences wound healing
  • Patients on non steroidal anti inflammatory drugs
  • smokers
  • uncooperative patients patients allergic to cyanoacrylate

Treatment and study plan

closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive

Procedure

Application of cyanoacrylate tissue adhesives over the surgical wound

closure of wound using braided silk suture

Procedure

suturing the surgical wound using braided black silk

Primary outcomes

  1. Postoperative pain

    Time frame: 1st postoperative day

    A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).

  2. postoperative pain

    Time frame: 2nd postoperative day

    A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).

  3. Postoperative pain

    Time frame: 3rd postoperative day

    A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).

  4. Postoperative pain

    Time frame: 4th postoperative day

    A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).

  5. postoperative pain

    Time frame: 5th postoperative day

    A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).

  6. wound healing

    Time frame: 7th postoperative day

    A 5 point early wound healing scale assessing wound healing after 7 postoperative days.

Sponsors and collaborators

Lead sponsor

Melaka Manipal Medical College

Other

Registry information

Official study title

Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures in the Closure of Intraoral Surgical Wounds- A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2021
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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