- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687680
Ozone Versus Conventional Socket Disinfection for Primary Dental Implant Stability
Comparison of Ozone and Conventional Socket Disinfection in Dental Implant Placement in Terms of Primary Stability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary implant stability is a key determinant of successful osseointegration and long-term implant survival. Various implant site disinfection methods have been proposed to reduce the microbial load before implant placement. Ozone possesses antimicrobial and biostimulatory properties and may improve the biological environment for implant healing compared with conventional implant site disinfection.
The purpose of this randomized split-mouth controlled clinical trial is to compare ozone implant site disinfection with conventional implant site disinfection in terms of primary and early secondary implant stability.
Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will be enrolled. According to a randomized split-mouth design, one implant site will receive ozone disinfection before implant placement, whereas the paired implant site will receive conventional disinfection. This design allows each participant to serve as their own control, thereby minimizing inter-individual variability.
Primary implant stability will be assessed immediately after implant placement using insertion torque measurements and resonance frequency analysis (Implant Stability Quotient, ISQ). Secondary implant stability will be evaluated by resonance frequency analysis at the 3-month follow-up during healing abutment placement. All clinical procedures will be standardized and performed by experienced clinicians. The study aims to determine whether ozone implant site disinfection provides superior implant stability during the early osseointegration period compared with conventional implant site disinfection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
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Adıyaman, Merkez, Turkey (Türkiye), 02030
- Faculty of Dentistry, Adıyaman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ozone Disinfection
Implant sites assigned to the experimental intervention receive ozone disinfection before dental implant placement.
|
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.
|
|
Experimental: Conventional Disinfection
Implant sites assigned to the control intervention receive conventional implant site disinfection before dental implant placement.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Implant Stability (Insertion Torque)
Time Frame: Immediately after implant placement
|
Primary implant stability will be assessed immediately after implant placement by measuring insertion torque (Ncm).
|
Immediately after implant placement
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HRU-25.18.55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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