NCT07687680

Brief Summary

This randomized split-mouth controlled clinical trial aims to compare the effects of ozone and conventional implant site disinfection on primary and early secondary implant stability. Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will receive ozone disinfection at one implant site and conventional disinfection at the paired site according to a randomized allocation. Implant stability will be assessed immediately after implant placement using insertion torque and resonance frequency analysis (Implant Stability Quotient, ISQ), and secondary stability will be evaluated by ISQ measurements at the 3-month follow-up during healing abutment placement. The study will determine whether ozone disinfection improves implant stability during the early osseointegration period.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 18, 2025

Completed
7 months 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
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 30, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Ozone therapyPrimary implant stabilityInsertion torqueSocket disinfectionOsseointegration

Outcome Measures

Primary Outcomes (1)

  • Primary Implant Stability (Insertion Torque)

    Primary implant stability will be assessed immediately after implant placement by measuring insertion torque (Ncm).

    Immediately after implant placement

Study Arms (2)

Ozone Disinfection

EXPERIMENTAL

Implant sites assigned to the experimental intervention receive ozone disinfection before dental implant placement.

Procedure: Ozone Implant Site Disinfection

Conventional Disinfection

EXPERIMENTAL

Implant sites assigned to the control intervention receive conventional implant site disinfection before dental implant placement.

Procedure: Conventional Socket Disinfection

Interventions

Before dental implant placement, the implant site assigned to the experimental intervention is disinfected using ozone according to the study protocol. In this randomized split-mouth design, each participant receives ozone disinfection at one implant site, while the paired contralateral or symmetrical implant site receives conventional disinfection. Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.

Ozone Disinfection

Before dental implant placement, the implant site assigned to the control intervention is disinfected using the conventional disinfection protocol. In this randomized split-mouth design, each participant receives conventional disinfection at one implant site, while the paired contralateral or symmetrical implant site receives ozone disinfection. Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.

Conventional Disinfection

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

You may not qualify if:

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are enrolled in a randomized split-mouth study design. Each participant receives both interventions at paired implant sites in symmetrical or contralateral edentulous areas. One implant site is assigned to ozone disinfection and the paired implant site to conventional disinfection before dental implant placement, allowing within-participant comparison.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant in Periodontology

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

November 18, 2025

Primary Completion

July 20, 2026

Study Completion

July 20, 2026

Last Updated

July 20, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because of participant confidentiality and institutional data-sharing policies.

Locations