Peri-Implant Marginal Bone Lossozone-ımplantNCT07687641
CBCT Assessment of Marginal Bone Changes With Ozone Therapy
A study testing Gaseous Ozone Application and Conventional Implant Placement in people with Peri-Implant Marginal Bone Loss and Dental Implantation, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Marginal Bone Loss, Dental Implantation
- What is being tested?
- Gaseous Ozone Application and Conventional Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2025to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Adıyaman University
Adıyaman, Merkez, 02030
About this study
Official title: CBCT Assessment of Peri-Implant Marginal Bone Changes Following Adjunctive Local Ozone Therapy: A Randomized Split-Mouth Clinical Trial
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).
Read the 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.
- Being tested
- Gaseous Ozone Application, Conventional Implant Placement
- Keywords
- Ozone, Dental Implant, Cone-Beam Computed Tomography, Alveolar Bone Loss
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaseous Ozone ApplicationProcedure or surgery
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.
Conventional Implant PlacementProcedure or surgery
Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.
| Study group | Role | What they receive |
|---|---|---|
| Gaseous Ozone Application | Experimental | 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. Receives: Procedure: Gaseous Ozone Application |
| Conventional Implant Placement | Active comparator | 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. Receives: Procedure: Conventional Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal Bone Level Around Dental Implants
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.
Measured: Baseline and 6 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start3 Sep 2025
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant Marginal Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective split-mouth randomized clinical trial used within-participant, site-level allocation. Each participant received both interventions concurrently: matched contralateral implant sites within the same jaw were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Thus, each participant served as their own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Başak Çakır Erdil, Adiyaman University
- Investigators
- METİN ÇALIŞIR, PhD, Principal investigator, Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687641
- Sponsor's protocol ID
- HRU-25.14.63
- Acronym
- ozone-ımplant
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBCT Assessment of Peri-Implant Marginal Bone Changes Following Adjunctive Local Ozone Therapy: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07687641
- Acronym / sponsor ID
- ozone-ımplant / HRU-25.14.63
- Keywords
- Ozone, Dental Implant, Cone-Beam Computed Tomography, Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective split-mouth randomized clinical trial used within-participant, site-level allocation. Each participant received both interventions concurrently: matched contralateral implant sites within the same jaw were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Thus, each participant served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Gaseous Ozone Application | Experimental | Procedure: Gaseous Ozone ApplicationWithin 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. |
| Conventional Implant Placement | Active comparator | Procedure: Conventional Implant PlacementWithin 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- Systemic diseases or medical conditions contraindicating implant surgery.
- Pregnancy.
- Smoking.
- Active oral infection or advanced periodontal disease.
- Insufficient bone volume requiring advanced bone augmentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaseous Ozone ApplicationGaseous 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. | Procedure or surgery | Gaseous Ozone Application |
| Conventional Implant PlacementImplants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application. | Procedure or surgery | Conventional Implant Placement |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Peri-Implant Marginal Bone Loss
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Active, not recruiting
Effect of Cover Screws and Healing Abutments on Marginal Bone Loss
Dental Implant, Marginal Bone Loss
Active, not recruitingObservational study
Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women
Postmenopausal Peri-implant Health, Postmenopausal Peri-mucositis
Active, not recruiting
Zirconia Implants: Practice-based Evidence
Dental Implants, Ceramic Implant
Active, not recruiting
Implant Placement Depth and Peri-Implant Tissue Outcomes
Dental Implant Placement, Soft Tissue Management in Subcrestal Dental Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
METİN ÇALIŞIR, PhD principal investigator
Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaseous Ozone Application and Conventional Implant Placement in people with Peri-Implant Marginal Bone Loss and Dental Implantation, run by Adiyaman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Marginal Bone Level Around Dental Implants (time frame: Baseline and 6 months after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.