ClinicalTrials.gg
Not yet recruitingNCT07106333Updated Aug 6, 2025

Assessment of Ozone Therapy for Management of Post-Extraction Localized Alveolar Osteitis

An interventional study of Topical Ozone Therapy and Irrigation with saline in Alveolar Osteitis, sponsored by Menoufia University. Not yet recruiting. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.

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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

This clinical study investigates the effectiveness of ozone therapy in comparison to conventional treatment for alveolar osteitis (AO), a common painful complication following tooth extraction. Forty patients diagnosed with dry socket will be randomly divided into two groups. Group A will receive traditional treatment with normal saline irrigation and analgesics, while Group B will be treated using ozonated water, ozonated gel, and analgesics. Both groups will be monitored over a two-week period to evaluate pain levels, healing progression, and other clinical indicators. The study aims to assess the palliative and regenerative benefits of ozone therapy in managing AO, potentially offering an alternative to conventional symptomatic treatments.

Read the detailed description

Alveolar osteitis (AO), commonly referred to as "dry socket," is a frequent postoperative complication following tooth extraction. It typically presents 1-3 days post-extraction with severe pain due to premature loss or breakdown of the blood clot within the extraction socket. While the exact pathogenesis remains controversial, enhanced fibrinolytic activity, bone trauma, and bacterial contamination are considered primary contributing factors. The incidence is notably higher in mandibular third molars.

Traditional management approaches-such as saline irrigation, antibiotics, and eugenol-based dressings-are often palliative and do not directly target the underlying cause. Ozone therapy, with its antimicrobial, analgesic, and wound-healing properties, has recently emerged as a potential alternative. Ozone, when applied in water or gel forms, is believed to promote clot stability, reduce pain, and enhance soft tissue regeneration.

Aim of the Study:

To assess and compare the palliative (pain-relieving) and regenerative (healing-promoting) effects of ozone therapy versus conventional treatment in patients suffering from alveolar osteitis.

02

Conditions studied

  • Alveolar Osteitis

Browse trials for

03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 41 interventional studies indexed under Dry Socket.

Browse Dry Socket studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Age: 18-60 years.

Patients undergoing simple (non-surgical) extractions.

Medically healthy individuals.

Exclusion criteria

Exclusion Criteria:

Patients already treated for AO.

Presence of systemic diseases affecting healing.

Severe infections or facial swelling.

Incomplete follow-up.

to ozone therapy: G6PD deficiency, hyperthyroidism, malignant hypertension, recent myocardial infarction.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Group A - Conventional Treatment (Control Group):

    Socket debridement and irrigation with normal saline. Pain management using Diclofenac potassium (50 mg TID). Follow-up at day 2, 3, 7, 10, and 14. Home care: saline mouth rinse.

    Other: Irrigation with saline

  • Other
    Group B-Ozone Therapy Group

    Socket debridement and irrigation with ozonated water. Application of ozonated gel into the socket using syringe with fine-tip applicator. Pain management using Diclofenac potassium (50 mg TID). Patients instructed to use ozonated water and gel at home daily. Follow-up at day 2, 3, 7, 10, and 14.

    Other: Topical Ozone Therapy

Interventions

  • OtherTopical Ozone Therapy

    The intervention involves local application of ozone in two forms: Ozonated Water - used for irrigation of the extraction socket. Ozonated Gel - applied topically inside the socket to promote healing and reduce pain. Both are used after socket debridement and bleeding provocation, followed by standard analgesic administration (Diclofenac potassium).

  • OtherIrrigation with saline

    The intervention involves irrigation with saline

06

What researchers measure

Primary outcomes

  1. Pain Reduction

    Patient-reported pain scale, categorized as: Severe Moderate Mild No pain

    Time frame: Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Up on request from the corresponding author

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07106333
Responsible party
Mohammed El-Sawy (Clinical Professor and principle investigator, Menoufia University) — Principal investigator
First posted
Aug 6, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 6, 2025

Study contacts

Mohammed A. El-Sawy, PhD
Contact
Dr_sawy@windowslive.com
00201061314522
Mohammed T. Khater, PhD
Contact
MohamedKhaterdentalsmile1234@gmail.com
00201003854552
Mohammed El-Sawy, PhD
study chair · Menoufia Universityt

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 Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion