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Active, Not Recruiting

NCT Number: NCT06705920

Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization

To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Dentistry

Cairo, Cairo Governorate, 11837, Egypt

About this study

All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients in a healthy systemic condition who required comprehensive dental treatment
  • Both genders with age group > 18 years old
  • Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion criteria

  • Patients with severe smoking habits >10 cig \\ day
  • Pregnant females, decisional impaired individuals and handicapped patients
  • Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
  • Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)

Treatment and study plan

topical oxygen gel

Drug

In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab

Primary outcomes

  1. Post operative wound healing.

    Time frame: 2 weeks

    Wound healing will be recorded in the 1st and 2 weeks postoperatively through Landry Wound Healing Index (LWHI) which evaluates the surgical site based on tissue color, response to touch, the marginality of the incision line, and extent of the area. The rating is from 1 = very poor to 5 = excellent.

Secondary outcomes

  1. Microbiological assessment

    Time frame: 2 weeks

    The collected samples of suture thread will be immersed in phosphate-buffered saline solution (PBS) immediately after their removal and This sample will be subsequently sent to the microbiology laboratory of the Faculty of Pharmacy of the British university in Egypt. The samples will be shaken vigorously for two minutes to separate the bacteria from the suture thread, and to obtain a homogeneous suspension. serial dilutions in saline will be subsequently prepared. 50 microliters of each dilution will be plated in Petri dishes containing different culture media.The blood agar, mannitol agar, MacConkey agar, and Sabouraud agar plates will be aerobically incubated at 37 °C for 24-48 hours. After incubation, the colony forming units (CFUs) will be counted and the total number of CFUs per milliliter of initial solution will be calculated

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • British University In Egypt

Registry information

Official study title

Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization : Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Jun 9, 2026

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.