EFFECT OF OZONE THERAPY ON MARGINAL BONE LEVELS AROUND DENTAL IMPLANTS (OZONE-IMPLANT)

June 30, 2026 updated by: Zeliha Başak Çakır Erdil, Adiyaman University

EFFECT OF OZONE TREATMENT APPLIED TO THE IMPLANT SOCKET ON MARGINAL BONE LEVELS: A RANDOMIZED CLINICAL STUDY

This prospective split-mouth randomized clinical trial was conducted to evaluate the effect of ozone treatment applied to fresh implant sockets on marginal bone levels and bone microarchitecture following immediate implant placement. Each participant received ozone treatment at one implant site and conventional treatment at the contralateral site according to a randomized allocation. Marginal bone levels and bone microarchitecture were evaluated using cone-beam computed tomography (CBCT) and fractal analysis over a 6-month follow-up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective split-mouth randomized clinical trial was conducted at the Department of Periodontology, Faculty of Dentistry, Adıyaman University. The study aimed to investigate whether the application of gaseous ozone to fresh implant sockets influences marginal bone levels and bone microarchitecture following immediate implant placement. Fifty participants requiring bilateral implant placement in comparable sites were enrolled. In accordance with the split-mouth design, one implant site received gaseous ozone treatment before implant placement, while the contralateral site served as the control, with treatment allocation determined by computer-generated randomization. Two participants were lost to follow-up, and the final analysis included 48 participants (152 implants). The primary outcome was the change in marginal bone levels after 6 months. Secondary outcomes included changes in bone microarchitecture assessed by fractal analysis of standardized radiographic images. Radiographic evaluations were performed using panoramic radiography and cone-beam computed tomography (CBCT).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Adıyaman, Merkez, Turkey (Türkiye), 02030
        • Faculty of Dentistry, Adıyaman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Systemically healthy individuals.
  • Ability to comply with the study protocol.
  • At least two missing teeth in symmetrical areas or different quadrants of the same jaw requiring implant placement.
  • Adequate alveolar bone volume for placement of standard diameter (3.5-4.0 mm) and length (8-12 mm) implants with at least 1.5 mm of surrounding bone.
  • Soft tissue phenotype ≥2 mm and keratinized mucosal width ≥2 mm at implant sites.
  • Written informed consent provided.

Exclusion Criteria:

  • Systemic diseases contraindicating implant surgery.
  • Pregnancy.
  • Insufficient alveolar bone volume requiring advanced bone augmentation.
  • Active oral infection.
  • Previous implant failure at the intended implant site.
  • Incomplete healing after recent tooth extraction.
  • Advanced periodontal disease.
  • Smoking.
  • Any contraindication to ozone therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gaseous Ozone
Implant sites received gaseous ozone application to the fresh implant socket immediately before immediate implant placement. In this split-mouth design, each participant received gaseous ozone at one randomized implant site.
Procedure: Gaseous Ozone Application
Gaseous ozone was applied to the fresh implant socket immediately before immediate implant placement.
Active Comparator: Control
Implant sites received conventional treatment without gaseous ozone application before immediate implant placement. In this split-mouth design, each participant received the control intervention at the contralateral randomized implant site.
Procedure: Conventional Implant Placement
Implant placement was performed without gaseous ozone application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Marginal Bone Level Around Dental Implants
Time Frame: Baseline and 6 months after implant placement
Marginal bone level was assessed using cone-beam computed tomography (CBCT) to compare implant sites treated with gaseous ozone and control sites after implant placement.
Baseline and 6 months after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adiyaman University

Investigators

  • Principal Investigator: METİN ÇALIŞIR, PhD, Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Actual)

May 18, 2026

Study Completion (Actual)

May 18, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HRU-25.05.39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because no data-sharing plan was established at the time of study design.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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