Alveolar OsteitisNCT07106333
Assessment of Ozone Therapy for Management of Post-Extraction Localized Alveolar Osteitis
A study testing Topical Ozone Therapy and Irrigation with saline in people with Alveolar Osteitis, run by Menoufia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Topical Ozone Therapy and Irrigation with saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Feb 2026
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years.
- Patients undergoing simple (non-surgical) extractions.
- Medically healthy individuals.
Who cannot join
- Patients already treated for AO.
- Presence of systemic diseases affecting healing.
- Severe infections or facial swelling.
- Incomplete follow-up.
- Contraindications to ozone therapy: G6PD deficiency, hyperthyroidism, malignant hypertension, recent myocardial infarction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Management of Post-Extraction Localized Alveolar Osteitis
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.
- Conditions
- Alveolar Osteitis
- Being tested
- Topical Ozone Therapy, Irrigation with saline
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ozone TherapyOther
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).
Irrigation with salineOther
The intervention involves irrigation with saline
| Study group | Role | What they receive |
|---|---|---|
| Group A - Conventional Treatment (Control Group): | Other | 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. Receives: Other: Irrigation with saline |
| Group B-Ozone Therapy Group | Other | 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. Receives: Other: Topical Ozone Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Patient-reported pain scale, categorized as:
Severe
Moderate
Mild
No pain
Measured: Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Model description
- intervention after wisdom tooth extraction either with saline or with topical ozone
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed El-Sawy, PhD, Study chair, Menoufia Universityt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106333
- Sponsor's protocol ID
- ADMNF-00225
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Post-Extraction Localized Alveolar Osteitis
- ClinicalTrials.gov ID
- NCT07106333
- Acronym / sponsor ID
- ADMNF-00225
- Conditions
- Alveolar Osteitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention after wisdom tooth extraction either with saline or with topical ozone
| Arm | Type | Receives |
|---|---|---|
| Group A - Conventional Treatment (Control Group): | Other | Other: Irrigation with salineSocket 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. |
| Group B-Ozone Therapy Group | Other | Other: Topical Ozone TherapySocket 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-60 years.
- Patients undergoing simple (non-surgical) extractions.
- Medically healthy individuals.
Key exclusion criteria (5 listed)
- Patients already treated for AO.
- Presence of systemic diseases affecting healing.
- Severe infections or facial swelling.
- Incomplete follow-up.
- Contraindications to ozone therapy: G6PD deficiency, hyperthyroidism, malignant hypertension, recent myocardial infarction.
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 |
|---|---|---|
| Topical Ozone TherapyThe 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). | Other | Group B-Ozone Therapy Group |
| Irrigation with salineThe intervention involves irrigation with saline | Other | Group A - Conventional Treatment (Control Group): |
Primary outcome
Pain Reduction
Time frame: Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14
Patient-reported pain scale, categorized as: Severe Moderate Mild No pain
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 6 Aug 2025.
- Individual participant dataSharing planned: No. Up on request from the corresponding author
Related trials for Alveolar Osteitis
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Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
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PERIodontal Disease, Microbiota and Miscarriage
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Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
Pain, Dry Socket
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.
Mohammed El-Sawy, PhD study chair
Menoufia Universityt
Questions about this trial
What is this clinical trial studying?
A study testing Topical Ozone Therapy and Irrigation with saline in people with Alveolar Osteitis, run by Menoufia University.
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 3 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammed A. El-Sawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14). 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 6 Aug 2025.