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

Ain Shams University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will Be Included in This Study

Treatments: Drug: topical oxygen gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06705920

24-042

Details and patient eligibility

About

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

Full description

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

control

No Intervention group

Description:

patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives

test

Active Comparator group

Description:

patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily

Treatment:

Drug: topical oxygen gel