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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

test

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

Group Type ACTIVE_COMPARATOR

topical oxygen gel

Intervention Type 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

Interventions

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topical oxygen gel

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes