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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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