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NCT Number: NCT06864559

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

To Compare 3 different suture materials used in oral surgery

Other

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

Primary outcomes

  1. Bacterial colonization

    Time frame: 7 days.

    Microbiological analysis: CFU and qPCR bacterial count.

  2. Level of inflammation

    Time frame: 7 days.

    The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

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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