Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study

March 3, 2025 updated by: Jose Manuel Alarcón Cordovilla, Universidad de Granada
Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The general or primary objective is:

• To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.

The specific or secondary objectives are:

  • To evaluate how each type of suture influences wound healing and the patient's postoperative period.
  • To study bacterial colonization in each type of suture.
  • To determine the tissue reaction and clinical characteristics of each suture.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
  • Age: patients aged 18 years or older.
  • ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Smoking patients.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Suture 1: Silk.
Silk suture.
Other: To Compare 3 different suture materials used in oral surgery
To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery.
Other Names:
  • 2028/CEIH/2021
Other: Suture 2: Non-absorbable polyamide monofilament.
Non-absorbable polyamide monofilament.
Other: To Compare 3 different suture materials used in oral surgery
To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery.
Other Names:
  • 2028/CEIH/2021
Other: Suture 3: Non-resorbable expanded polytetrafluoroethylene.
Non-resorbable expanded polytetrafluoroethylene.
Other: To Compare 3 different suture materials used in oral surgery
To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery.
Other Names:
  • 2028/CEIH/2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial colonization
Time Frame: 7 days.
Microbiological analysis: CFU and qPCR bacterial count.
7 days.
Level of inflammation
Time Frame: 7 days.
The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).
7 days.

Collaborators and Investigators

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

Sponsor

Universidad de Granada

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2028/CEIH/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Oral Infection

Clinical Trials on To Compare 3 different suture materials used in oral surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe