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

NCT ID: NCT07106333

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-02-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

Irrigation with saline

Intervention Type: OTHER

The intervention involves irrigation with saline

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.

Group Type: OTHER

Topical Ozone Therapy

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Irrigation with saline

The intervention involves irrigation with saline

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed El-Sawy

Clinical Professor and principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed El-Sawy, PhD

Role: STUDY_CHAIR

Menoufia Universityt

Central Contacts

Mohammed A. El-Sawy, PhD

Role: CONTACT

Dr_sawy@windowslive.com

00201061314522

Mohammed T. Khater, PhD

Role: CONTACT

MohamedKhaterdentalsmile1234@gmail.com

00201003854552

Other Identifiers

ADMNF-00225

Identifier Type: -

Identifier Source: org_study_id