Effect of Ozone Therapy on Marginal Bone Levels Around Dental Implants (ozone-ımplant)
September 4, 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 study examined whether adding local gaseous ozone to standard dental implant treatment could reduce early bone loss around implants.
Fifty adults requiring matched implants on opposite sides of the same jaw participated.
Within each participant, matched implant sites were randomly assigned to ozone treatment or standard treatment without ozone.
Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Changes in marginal bone levels from baseline to 6 months were assessed using cone-beam computed tomography (CBCT).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This prospective, split-mouth randomized clinical trial was conducted at the Department of Periodontology, Faculty of Dentistry, Adıyaman University.
Participants required implant placement at matched contralateral posterior sites within the same jaw.
Within each participant, matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone.
Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Fifty participants were enrolled; two were lost to follow-up, and 48 participants with 152 implants completed the study.
The final analysis included 76 ozone-treated and 76 control implants.
The primary outcome was the change in peri-implant marginal bone level from baseline to 6 months, assessed using cone-beam computed tomography at the buccal, palatal/lingual, mesial, and distal implant surfaces.
The outcome assessor was blinded to treatment allocation.
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
-
-
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 to 65 years.
- Systemically healthy individuals.
- Ability to comply with the study procedures and follow-up visits.
- Requirement for implant placement at matched contralateral posterior sites within the same jaw.
- Healed edentulous sites suitable for conventional implant placement.
- Adequate alveolar bone volume for placement of implants measuring 3.5-4.0 mm in diameter and 8-12 mm in length without the need for advanced bone augmentation, with at least 1.5 mm of surrounding bone.
- Initial soft-tissue thickness of at least 2 mm and keratinized mucosal width of at least 2 mm at the implant sites.
- Provision of written informed consent.
Exclusion Criteria:
- Systemic diseases or medical conditions contraindicating implant surgery.
- Pregnancy.
- Smoking.
- Active oral infection or advanced periodontal disease.
- Insufficient bone volume requiring advanced bone augmentation.
- Incomplete healing at the intended implant site following recent tooth extraction.
- Previous implant failure at the intended implant site.
- 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 Application
Within each participant, one or more matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment.
Ozone was applied to the surgically prepared implant socket before implant placement and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7.
All sites also received standard surgical and postoperative care.
|
Gaseous ozone was applied to the surgically prepared implant socket before implant placement.
Following suturing, ozone was applied locally to the peri-implant surgical site and was repeated on postoperative days 1, 3, 5, and 7.
|
|
Active Comparator: Conventional Implant Placement
Within each participant, the corresponding contralateral matched implant site or sites were allocated to the control treatment.
These sites received conventional implant placement and standard postoperative care without ozone application at any time point.
|
Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative 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
|
Using cone-beam computed tomography (CBCT), the vertical distance from the implant shoulder to the first bone-to-implant contact was measured in millimeters at the buccal, palatal/lingual, mesial, and distal surfaces at baseline and 6 months.
For each surface, marginal bone level change was calculated as the 6-month distance minus the baseline distance; positive values indicated greater marginal bone loss.
Combined buccolingual and mesiodistal measurements were calculated by averaging the corresponding surface measurements.
Changes were compared between matched ozone-treated and control implant sites.
|
Baseline and 6 months after implant placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 3, 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)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 4, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRU-25.14.63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared because the informed consent obtained from participants did not include external sharing of individual-level data.
Aggregated study findings will be reported in the publication.
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.