Infection, Surgical SiteNCT07904143
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
A study testing Incision and drainage + Povidone-iodine irrigation and Incision and drainage + ozonated distilled in people with Infection, Surgical Site, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- Incision and drainage + Povidone-iodine irrigation and Incision and drainage + ozonated distilled
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
Faculty of Dentistry, (203) 4868308
Reham Khaled, BDS
About this study
Official title: Comparison Between Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections (Randomized Controlled Clinical Trial)
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.
- Conditions
- Infection, Surgical Site
- Being tested
- Incision and drainage + Povidone-iodine irrigation, Incision and drainage + ozonated distilled
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision and drainage + Povidone-iodine irrigationProcedure or surgery
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.
Incision and drainage + ozonated distilledProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Procedure: Incision and drainage + Povidone-iodine irrigation |
| Study | Experimental | Not described Receives: Procedure: Incision and drainage + ozonated distilled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in wound size
Extraoral wound healing will be assessed using the Southampton Wound Assessment Scale (SWAS). 0: Normal healing
- Normal healing with mild bruising and erythema.
- Erythema and other signs of inflammation
- Clear or serosanguinous discharge
- Purulent discharge (pus)
- deep wound infection
Measured: up to 10 days
Secondary outcomes (3)
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.
Measured: up to 10 days
change in inflammatory biomarkers
Serial assessment of inflammatory biomarkers
Measured: up to 7 days
Duration of drain placement
Number of days of drain placement will be recorded as an indicator of infection resolution and treatment response
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904143
- Sponsor's protocol ID
- 1389-08/2026
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07904143
- Acronym / sponsor ID
- 1389-08/2026
- Conditions
- Infection, Surgical Site
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Incision and drainage + Povidone-iodine irrigation |
| Study | Experimental | Procedure: Incision and drainage + ozonated distilled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incision and drainage + Povidone-iodine irrigationPatients suffering from suprahyoid maxillofacial space infections will be treated with incision and drainage and then daily irrigation using povidone-iodine together with empirical antibiotics. | Procedure or surgery | Control |
| Incision and drainage + ozonated distilledPatients suffering from suprahyoid maxillofacial space infections will be treated with incision and drainage then daily irrigation using ozonated distilled water together with empirical antibiotics. | Procedure or surgery | Study |
Primary outcome
Reduction in wound size
Time frame: up to 10 days
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
3 secondary outcomes
Change in pain scores
Time frame: up to 10 days
change in inflammatory biomarkers
Time frame: up to 7 days
Duration of drain placement
Time frame: during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incision and drainage + Povidone-iodine irrigation and Incision and drainage + ozonated distilled in people with Infection, Surgical Site, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Khaled, BDS (01123334108, reiham.khaled@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in wound size (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.