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Not yet recruitingNCT07904143Updated Oct 29, 2026

Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections

An interventional study of Incision and drainage + Povidone-iodine irrigation and Incision and drainage + ozonated distilled in Infection, Surgical Site, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Maxillofacial space infections are among the most common infections encountered in oral and maxillofacial surgery and may progress to severe, life-threatening complications if not properly managed, making their treatment a critical component of maxillofacial surgical practice(1).In recent years, Ozonated distilled water has emerged as a promising alternative owing to its potent antimicrobial activity against bacteria, viruses, and fungi, while demonstrating minimal toxicity to host tissues.(2-3) Aim: thus, the aim of the present study is to investigate whether ozonated distilled water irrigation in patients experiencing facial space infection after surgical incision and drainage of the maxillofacial space infection would result in resolution of infection, reduction of postoperative pain and reduction of wound size.

02

Conditions studied

  • Infection, Surgical Site
03

In context

Surgical Wound Infection

692 studies on the registry are indexed under Surgical Wound Infection; 147 are open to participants now.

This study's planned enrollment of 26 is below the median of 200 across 530 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Alexandria University is the lead sponsor of 596 studies on the registry; 134 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with involvement of one or more maxillofacial space infections (suprahyoid) are indicated for incision and surgical drainage after failure of conservative medical treatment.
  • No gender predilection.

Exclusion criteria

Exclusion Criteria:

  • Secondary space infection due to malignant tumors.
  • A history of surgical intervention prior to admission.
  • Pregnant or lactating females.
  • Medically compromised patients.
  • Previously drained or recurrent neck infection.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Active comparator
    Control

    Procedure: Incision and drainage + Povidone-iodine irrigation

  • Experimental
    Study

    Procedure: Incision and drainage + ozonated distilled

Interventions

  • ProcedureIncision and drainage + Povidone-iodine irrigation

    Patients suffering from suprahyoid maxillofacial space infections will be treated with incision and drainage and then daily irrigation using povidone-iodine together with empirical antibiotics.

  • ProcedureIncision and drainage + ozonated distilled

    Patients suffering from suprahyoid maxillofacial space infections will be treated with incision and drainage then daily irrigation using ozonated distilled water together with empirical antibiotics.

06

What researchers measure

Primary outcomes

  1. Reduction in wound size

    Extraoral wound healing will be assessed using the Southampton Wound Assessment Scale (SWAS). 0: Normal healing 1. Normal healing with mild bruising and erythema. 2. Erythema and other signs of inflammation 3. Clear or serosanguinous discharge 4. Purulent discharge (pus) 5. deep wound infection

    Time frame: up to 10 days

Secondary outcomes

  1. Change in pain scores

    Numerical Rating score (NRS) will be used. The patients will be asked to choose the most appropriate number that describes their current pain. 1-3: Mild Pain (acceptable pain), 4-6: Moderate, 7-10: Severe Pain. Subjects will be asked to qualify the experienced pain as acceptable or not.

    Time frame: up to 10 days

  2. change in inflammatory biomarkers

    Serial assessment of inflammatory biomarkers

    Time frame: up to 7 days

  3. Duration of drain placement

    Number of days of drain placement will be recorded as an indicator of infection resolution and treatment response

    Time frame: during the procedure

07

Study locations

1 site
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Azarita 00203, Egypt
    • Faculty of Dentistry · Contact(203) 4868308
    • Reham Khaled, BDS · Principal investigator
    • Amany Elrayess, PhD · Sub investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

Of 189 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 3 months is below that.

Counting every sponsor, half of 196 studies reached it within 24 months; a quarter within 13 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 29, 2026
StartEst.
Oct 28, 2026
Primary completionEst.
Jan 30, 2027
CompletionEst.
Feb 28, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07904143
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Oct 28, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Reham Khaled, BDS
Contact
reiham.khaled@gmail.com
01123334108

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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