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Not yet recruiting NCT07106333

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

No phase Interventional Alveolar Osteitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topical Ozone Therapy, Irrigation with saline.
Who it may be relevant to
Registry conditions: Alveolar Osteitis. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Management of Post-Extraction Localized Alveolar Osteitis

Overview

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.

Interventions

  • Other Topical 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).
  • Other Irrigation with saline
    The intervention involves irrigation with saline

Primary outcome measures

  • Pain Reduction [Time frame: Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07106333 · ADMNF-00225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗