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

NCT06864559 | Not Yet Recruiting

• 1 other identifier: 2028/CEIH/2021
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Wound Healing Complication; Oral Surgery; Third Molar Extraction; Oral Infection

Outcome Measures

Primary Outcomes (2)

• Bacterial colonization

  Microbiological analysis: CFU and qPCR bacterial count.

  7 days.

• Level of inflammation

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

  7 days.

Study Arms (3)

Suture 1: Silk.

OTHER

Silk suture.

Other: To Compare 3 different suture materials used in oral surgery

Suture 2: Non-absorbable polyamide monofilament.

OTHER

Non-absorbable polyamide monofilament.

Other: To Compare 3 different suture materials used in oral surgery

Suture 3: Non-resorbable expanded polytetrafluoroethylene.

OTHER

Non-resorbable expanded polytetrafluoroethylene.

Other: To Compare 3 different suture materials used in oral surgery

Interventions

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.

Also known as: 2028/CEIH/2021

Suture 1: Silk.; Suture 2: Non-absorbable polyamide monofilament.; Suture 3: Non-resorbable expanded polytetrafluoroethylene.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• Smoking patients.

Sponsors & Collaborators

• Universidad de Granada: lead

MeSH Terms

Interventions

Surgery, Oral

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS (University of Granada), MSc (Oral Surgery)

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03