Ozone Therapy After Open Flap Debridement in Periodontitis

NCT07551297 | Completed

• 1 other identifier: ATAUNI-PERIO-OFD-OZONE-2026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic inflammatory disease characterized by the destruction of supporting periodontal tissues. Open flap debridement (OFD) is a commonly used surgical approach for the treatment of deep periodontal pockets when non-surgical therapy is insufficient. However, complete elimination of pathogenic microorganisms remains challenging. Ozone therapy has been proposed as an adjunctive treatment due to its antimicrobial, anti-inflammatory, and wound healing properties. This randomized split-mouth clinical trial aims to evaluate the clinical effectiveness of adjunctive ozone therapy in patients with Stage III periodontitis undergoing OFD. A total of 24 systemically healthy patients diagnosed with Stage III periodontitis were included in the study. In each patient, one side was randomly assigned to receive OFD combined with ozone therapy (test group), while the contralateral side received OFD alone (control group). Clinical periodontal parameters, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL), were recorded at baseline and at 6 and 12 months after treatment. The study aims to determine whether adjunctive ozone therapy improves clinical outcomes compared to conventional OFD alone.

Conditions

Periodontitis; Stage III Periodontitis

Keywords

Ozone Therapy; Open Flap Debridement; Periodontal Surgery; Split-Mouth Study; Clinical Attachment Level; Probing Pocket Depth; Periodontal Treatment; Adjunctive Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Probing Pocket Depth (PPD)

  Probing pocket depth (PPD) will be measured in millimeters using a periodontal probe at baseline and 12 months after treatment. The outcome represents the change in PPD between baseline and follow-up.

  Baseline to 12 months

Secondary Outcomes (4)

• Change in Clinical Attachment Level (CAL)

  Baseline to 12 months

• Change in Bleeding on Probing (BOP)

  Baseline to 12 months

• Change in Gingival Index (GI)

  Baseline to 12 months

• Change in Plaque Index (PI)

  Baseline to 12 months

Study Arms (2)

Ozone Group

EXPERIMENTAL

Sites treated with open flap debridement combined with adjunctive ozone therapy.

Procedure: Open Flap Debridement; Device: Ozone Therapy

Control Group

ACTIVE COMPARATOR

Sites treated with open flap debridement alone without adjunctive ozone therapy.

Procedure: Open Flap Debridement

Interventions

Open Flap Debridement PROCEDURE

Open flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets.

Control Group; Ozone Group

Ozone Therapy DEVICE

Adjunctive ozone therapy was applied to the test sites following open flap debridement using an ozone delivery device according to the manufacturer's instructions.

Ozone Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 25 and 65 years
• Diagnosed with Stage III periodontitis
• Presence of at least 20 teeth
• Presence of periodontal pockets ≥5 mm in at least two teeth
• Indication for open flap debridement
• Systemically healthy individuals
• No periodontal treatment within the last 6 months

You may not qualify if:

• Pregnant or breastfeeding women
• Presence of systemic diseases that may affect periodontal healing
• Use of antibiotics or anti-inflammatory drugs within the last 6 months
• Smoking or tobacco use
• History of periodontal treatment within the last 6 months
• Patients with poor oral hygiene compliance

Sponsors & Collaborators

• Alparslan Dilsiz: lead

Study Sites (1)

Ataturk University Faculty of Dentistry, Department of Periodontology

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

• Mangal S, Kaushal S, Lal N, Pathak AK, Agarwal B, Shukla S. Comparison of ozone therapy and antimicrobial photodynamic therapy in periodontitis: A randomized clinical trial. J Oral Biol Craniofac Res. 2026 Mar-Apr;16(2):101393. doi: 10.1016/j.jobcr.2025.12.011. Epub 2026 Jan 13.

  PMID: 41584216 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study was designed as a randomized split-mouth clinical trial. In each participant, contralateral sites were randomly assigned to either the test group (open flap debridement with adjunctive ozone therapy) or the control group (open flap debridement alone).

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 24, 2026
• Study Start: January 1, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 18, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)