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

M

Menoufia University

Status

Not yet enrolling

Conditions

Alveolar Osteitis

Treatments

Other: Topical Ozone Therapy
Other: Irrigation with saline

Study type

Interventional

Funder types

Other

Identifiers

NCT07106333
ADMNF-00225

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Group A - Conventional Treatment (Control Group):
Other group
Description:
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.
Treatment:
Other: Irrigation with saline
Group B-Ozone Therapy Group
Other group
Description:
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.
Treatment:
Other: Topical Ozone Therapy

Trial contacts and locations

0

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Central trial contact

Mohammed T. Khater, PhD; Mohammed A. El-Sawy, PhD

Data sourced from clinicaltrials.gov

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