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NCT Number: NCT07687641

Effect of Ozone Therapy on Marginal Bone Levels Around Dental Implants

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.

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Key information

Conditions

Immediate Dental Implant Placement Effects of Gaseous Ozone on Marginal Bone Levels

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gaseous Ozone Application

Procedure

Gaseous ozone was applied to the fresh implant socket immediately before immediate implant placement.

Conventional Implant Placement

Procedure

Implant placement was performed without gaseous ozone application.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Official study title

Effect of Ozone Treatment Applied to the Implant Socket on Marginal Bone Levels: A Randomized Clinical Study

Acronym: ozone-ımplant

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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