- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849856
Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches
April 8, 2026 updated by: Meltem Ozdemir Kabalak, Hacettepe University
Clinical and Biochemical Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches
Peri-implant diseases, which are the most common biological complications of dental implants, are inflammatory diseases characterized by soft tissue inflammation and loss of supporting bone tissue in the tissues around the implant.
The most basic factor in the onset of peri-implant diseases is bacterial biofilm formation.
Therefore, the gold standard in its treatment is plaque removal.
It has been stated that mechanical treatments with conventional plaque removal methods, usually applied using curettes in the treatment of peri-implantitis, are unpredictable and that positive clinical results are valid for short periods such as 6-12 months.
This result can be explained by the inability to provide sufficient debridement on the rough implant surface.
For this reason, it has been shown that the use of air abrasion systems based on the principle of cleaning the surfaces by applying an abrasive powder with compressed air may be beneficial in order to increase the success of the treatment.
When the literature is reviewed, it is seen that there is no standard clinical protocol for the use of air abrasion devices as a mechanical debridement method for non-surgical peri-implantitis treatment.
In the pathogenesis of peri-implant disease, cytokines that manage the inflammatory process play a major role.
RANK ligand (RANKL), osteoprotegerin (OPG) and TWEAK are biomarkers that play a role in bone metabolism.
Examination of cytokines and such biomarkers that play a role in bone metabolism in the peri-implant crevicular fluid (PIOS) at the initial stage and during the post-treatment follow-up processes and recording clinical findings may be useful in evaluating the effects of alternative treatment methods on disease control.
For this purpose, it is planned to include 60 patients aged between 18-65 with dental implants with a probing depth of 6 mm or more in one or more areas of the mouth in the study.
Patients will be randomized into 3 groups as A: Non-surgcal treatment with titanium curettes, B: Non-surgcal treatment with air abrasion device and C: Non-surgcal treatment with titanium curettes + air abrasion device.
Initial clinical periodontal parameters of all patients will be recorded and PIOS samples will be obtained.
Following appropriate treatments for the determined group, clinical indices will be recorded and PIOS sampling will be repeated in the 3rd and 6th months.
IL-10, IL-17, RANKL, OPG and TWEAK levels in the PIOS samples will be determined by ELISA test and the findings will be evaluated with appropriate statistical analyses.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06100
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Who have not received any periodontal treatment in the last 6 months,
- Who have not used any medication (antibiotics, anti-inflammatory drugs, antibacterial mouthwashes, corticosteroids) that could affect the results of the study in the last 3 months,
- Who have at least one implant with a probing depth of 6 mm or deeper in one or more areas in the mouth, and the implant in question has been in function for at least 1 year,
- Between the ages of 18-65,
- Individuals who approve the informed consent form will be included in the study.
Exclusion Criteria:
Individuals who:
- have a systemic disease that may affect the periodontium,
- regularly use medication that may affect the periodontium,
- smoke,
- are pregnant or lactating,
- are sensitive to chlorhexidine,
- have more than 50% bone loss around their current implant(s),
- do not approve the informed consent form will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment of peri-implantitis using titanium curette
Non-surgical peri-implantitis treatment will be performed using titanium curettes suitable for use on implant surfaces
|
Titanium curette will be used for non-surgical treatment of peri-implantitis
|
|
Experimental: Treatment of peri-implantitis using Airflow device
Non-surgical peri-implantitis treatment will be performed using erythritol powder with Airflow device
|
Airflow device with erythritol powder will be used in the treatment of non-surgical peri-implantitis
|
|
Experimental: Treatment of peri-implantitis using titanium curette + Airflow device
Non-surgical peri-implantitis treatment will be performed using titanium curette and erythritol powder with Airflow device
|
Titanium curette will be used for non-surgical treatment of peri-implantitis
Airflow device with erythritol powder will be used in the treatment of non-surgical peri-implantitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Depth
Time Frame: From enrollment to the 6 months after treatment.
|
The distance between the gingival margin and the base of the pocket will be measured with a periodontal probe.
|
From enrollment to the 6 months after treatment.
|
|
Bleeding on probing
Time Frame: From enrollment to the 6 months after treatment
|
Bleeding occurring within 10 seconds after probing will be evaluated as dichotomous (+/-).
|
From enrollment to the 6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-10, RANKL, OPG, TWEAK, and IL-17
Time Frame: 3rd and 6th months after treatment
|
IL-10, RANKL, OPG, TWEAK, and IL-17 levels will be analyzed by ELISA test.
|
3rd and 6th months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2023
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
January 20, 2025
First Submitted That Met QC Criteria
February 23, 2025
First Posted (Actual)
February 27, 2025
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THD-2023-20873
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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