CBCT Assessment of Marginal Bone Changes With Ozone Therapy

NCT07687641 | Completed

• 1 other identifier: HRU-25.14.63
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Peri-Implant Marginal Bone Loss; Dental Implantation

Keywords

Ozone; Dental Implant; Cone-Beam Computed Tomography; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months after implant placement

Study Arms (2)

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.

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.

Procedure: Conventional Implant Placement

Interventions

Gaseous Ozone Application PROCEDURE

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.

Gaseous Ozone Application

Conventional Implant Placement PROCEDURE

Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.

Conventional Implant Placement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• METİN ÇALIŞIR, PhD

  Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiographic outcome assessor was blinded to treatment allocation. The operating surgeon was not blinded because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant in Periodontology

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: September 3, 2025
• Primary Completion: May 18, 2026
• Study Completion: May 18, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)