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CompletedNCT04898816Updated Apr 6, 2023

Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

An interventional study of closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive and closure of wound using braided silk suture in Wound Heal, sponsored by Melaka Manipal Medical College. Completed at 1 site in Malaysia. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Melaka Manipal Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2020, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
17 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Wound Heal
03

In context

Lead sponsor

Melaka Manipal Medical College is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients taking any medications that influences wound healing
  • Patients on non steroidal anti inflammatory drugs
  • smokers
  • uncooperative patients patients allergic to cyanoacrylate
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Group A

    Application of cyanoacrylate tissue adhesive over the surgical wound

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

  • Active comparator
    Group B

    Suturing the surgical wound using braided black silk

    Procedure: closure of wound using braided silk suture

Interventions

  • Procedureclosure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive

    Application of cyanoacrylate tissue adhesives over the surgical wound

  • Procedureclosure of wound using braided silk suture

    suturing the surgical wound using braided black silk

06

What researchers measure

Primary outcomes

  1. Postoperative pain

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

    Time frame: 1st postoperative day

  2. postoperative pain

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

    Time frame: 2nd postoperative day

  3. Postoperative pain

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

    Time frame: 3rd postoperative day

  4. Postoperative pain

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

    Time frame: 4th postoperative day

  5. postoperative pain

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

    Time frame: 5th postoperative day

  6. wound healing

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

    Time frame: 7th postoperative day

07

Study locations

1 site
  • Melaka Manipal Medical College
    Melaka Tengah, Melaka 75150, Malaysia
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

Time frame: 1 month

Access criteria: Study protocol will be provided only if requested through a proper channel, dean of college , with proper justification.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2020 to primary completion in Apr 2021, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2021
First posted
May 24, 2021
StartActual
Mar 30, 2020
Primary completionActual
Apr 25, 2021
CompletionActual
Apr 25, 2021
Last update
Apr 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04898816
Lead sponsor
Melaka Manipal Medical College
Responsible party
Abdul Kalam Azad (Assistant Professor, Melaka Manipal Medical College) — Principal investigator
First posted
May 24, 2021
Start date
Mar 30, 2020
Primary completion
Apr 25, 2021
Completion
Apr 25, 2021
Last update
Apr 6, 2023

Study contacts

abdul K azad
principal investigator · Melaka Manipal Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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