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NCT Number: NCT07106333

Assessment of Ozone Therapy for 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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: 18-60 years.

Patients undergoing simple (non-surgical) extractions.

Medically healthy individuals.

Exclusion criteria

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.

Treatment and study plan

Topical Ozone Therapy

Other

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 saline

Other

The intervention involves irrigation with saline

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed A. El-Sawy, PhD

CONTACT

[email protected]

00201061314522

Mohammed T. Khater, PhD

CONTACT

[email protected]

00201003854552

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Management of Post-Extraction Localized Alveolar Osteitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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