NCT07687641

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Bone levelOzoneOsseointegrationDental ImplantCone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Change in Marginal Bone Level Around Dental Implants

    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

Study Arms (2)

Gaseous Ozone

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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

Gaseous Ozone

Implant placement was performed without gaseous ozone application.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

Location

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This was a prospective split-mouth randomized clinical trial. Each participant received both interventions: one implant site was allocated to gaseous ozone treatment and the contralateral comparable implant site served as the control. The allocation of the intervention side was determined using a computer-generated randomization sequence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant in Periodontology

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

March 12, 2025

Primary Completion

May 18, 2026

Study Completion

May 18, 2026

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations