Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Mandibular Impacted Wisdom Surgery

February 6, 2025 updated by: Serap Keskin Tunc, Yuzuncu Yıl University

Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Dental Surgery

In this study, bilateral It is aimed to compare the efficacy of tissue adhesive (Periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study carried out on a total of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilateral bilateral teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was determined as the control group and the wound was closed with silk suture. The selected party was determined by the closed envelope method. After the first impacted tooth was extracted, it was waited until the wound healed and the symptoms disappeared completely, then the other tooth was extracted. In both tooth extractions, wound healing, edema and trismus were evaluated on the 3rd and 7th days. Wound healing was evaluated as good, acceptable and bad. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65080
        • Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy individuals aged 18-35 years who accepted the study conditions and had bilateral, bone or mucosal retention, and completely impacted wisdom teeth in the similar position with an indication for extraction due to prophylactic or orthodontic treatment in the lower jaw were included in the study.

Exclusion Criteria:

  • Individuals with any systemic disease
  • Individuals with a history of allergy to the drugs to be used in the study
  • Pregnant and breastfeeding individuals
  • Individuals with pain, swelling or trismus in the last 10 days
  • Individuals with different positions on the right and left sides
  • Individuals who did not sign the voluntary consent form
  • Individuals with pathology in the impacted tooth area
  • Individuals with limited mouth opening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tissue adhesive (Periacryl 90)
After the extraction of the impacted lower wisdom tooth, the wound area was closed using tissue adhesive.
Procedure: Impacted lower wisdom tooth extraction
One of the most frequently performed procedures in maxillofacial surgery is impacted wisdom tooth surgery. An impacted tooth is defined as a tooth that is not fully or partially erupted and is blocked from eruption by another tooth, bone, or soft tissue, and thus has a low probability of eruption. The tooth is blocked from eruption by adjacent hard or soft tissue, including bone or dense soft tissue. The most common complications after impacted wisdom tooth surgery are pain, edema, trismus, and alveolar osteitis.
Active Comparator: Silk suture
After the extraction of the impacted lower wisdom tooth, the wound area was closed using silk sutures.
Procedure: Impacted lower wisdom tooth extraction
One of the most frequently performed procedures in maxillofacial surgery is impacted wisdom tooth surgery. An impacted tooth is defined as a tooth that is not fully or partially erupted and is blocked from eruption by another tooth, bone, or soft tissue, and thus has a low probability of eruption. The tooth is blocked from eruption by adjacent hard or soft tissue, including bone or dense soft tissue. The most common complications after impacted wisdom tooth surgery are pain, edema, trismus, and alveolar osteitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema
Time Frame: 3. and 7. days
In order to evaluate edema, the distances between points marked extra orally in 5 different regions on the face were measured and recorded in mm (angulus-tragus point, angulus-lateral corner of the eye, angulus-nasal wing, angulus-lateral commissure, angulus-pogonion point).
3. and 7. days
Trismus
Time Frame: 3. and 7. days
The evaluation of trismus was evaluated by measuring the mouth opening before the operation and also on the 3rd and 7th days after the operation. The patients were asked to open their mouths as much as possible and the distance between the incisal edges of the lower and upper central incisors was measured in millimeters with the help of a precision ruler. This process was repeated 3 times for each measurement and the arithmetic average of the values found was taken.
3. and 7. days
Wound Healing
Time Frame: 3. and 7. days
All patients were called for follow-up visits on the 3rd day and 1 week later and were examined by the same physician. During the follow-up visits, the status of wound healing was evaluated in 3 different statuses. These 3 statuses were recorded as good, acceptable and poor. Wound healing deteriorated from good to poor.
3. and 7. days
VAS Pain Scor
Time Frame: 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.
VAS (Visual Analog Scale) was used for pain assessment. VAS pain assessment includes scores between 0 and 10. (0: no pain; 10: unbearable pain.) As the score increases, the pain worsens.
3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYU-04/18.05.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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