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

NCT07106333 | Not Yet Recruiting

• 1 other identifier: ADMNF-00225
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Osteitis

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  Patient-reported pain scale, categorized as: Severe Moderate Mild No pain

  Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14

Study Arms (2)

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.

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.

Other: Topical Ozone Therapy

Interventions

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).

Group B-Ozone Therapy Group

Irrigation with saline OTHER

The intervention involves irrigation with saline

Group A - Conventional Treatment (Control Group):

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years.
• Patients undergoing simple (non-surgical) extractions.
• Medically healthy individuals.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Dry Socket

Interventions

Therapeutic Irrigation; Sodium Chloride

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohammed El-Sawy, PhD

  Menoufia Universityt

  STUDY CHAIR

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

00201061314522; Dr_sawy@windowslive.com

Mohammed T. Khater, PhD

CONTACT

00201003854552; MohamedKhaterdentalsmile1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and principle investigator

Model Details: intervention after wisdom tooth extraction either with saline or with topical ozone

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share