PeriimplantitisNCT06849856
Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches
A study testing non-surgical peri-implantitis therapy with airflow device and non-surgical peri-implantitis therapy with titanium curette in people with Periimplantitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periimplantitis
- What is being tested?
- non-surgical peri-implantitis therapy with airflow device and non-surgical peri-implantitis therapy with titanium curette
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Periimplantitis
- Being tested
- non-surgical peri-implantitis therapy with airflow device, non-surgical peri-implantitis therapy with titanium curette
- Keywords
- peri-implantitis, airflow
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical peri-implantitis therapy with airflow deviceDevice
Airflow device with erythritol powder will be used in the treatment of non-surgical peri-implantitis
non-surgical peri-implantitis therapy with titanium curetteProcedure or surgery
Titanium curette will be used for non-surgical treatment of peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| Treatment of peri-implantitis using titanium curette | Active comparator | Non-surgical peri-implantitis treatment will be performed using titanium curettes suitable for use on implant surfaces Receives: Procedure: non-surgical peri-implantitis therapy with titanium curette |
| Treatment of peri-implantitis using Airflow device | Experimental | Non-surgical peri-implantitis treatment will be performed using erythritol powder with Airflow device Receives: Device: non-surgical peri-implantitis therapy with airflow device |
| Treatment of peri-implantitis using titanium curette + Airflow device | Experimental | Non-surgical peri-implantitis treatment will be performed using titanium curette and erythritol powder with Airflow device Receives: Device: non-surgical peri-implantitis therapy with airflow device; Procedure: non-surgical peri-implantitis therapy with titanium curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
The distance between the gingival margin and the base of the pocket will be measured with a periodontal probe.
Measured: From enrollment to the 6 months after treatment.
Bleeding on probing
Bleeding occurring within 10 seconds after probing will be evaluated as dichotomous (+/-).
Measured: From enrollment to the 6 months after treatment
Secondary outcomes (1)
IL-10, RANKL, OPG, TWEAK, and IL-17
IL-10, RANKL, OPG, TWEAK, and IL-17 levels will be analyzed by ELISA test.
Measured: 3rd and 6th months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Dec 2023
- Primary completion15 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Ozdemir Kabalak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849856
- Sponsor's protocol ID
- THD-2023-20873
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches
- ClinicalTrials.gov ID
- NCT06849856
- Acronym / sponsor ID
- THD-2023-20873
- Conditions
- Periimplantitis
- Keywords
- peri-implantitis, airflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment of peri-implantitis using titanium curette | Active comparator | Procedure: non-surgical peri-implantitis therapy with titanium curetteNon-surgical peri-implantitis treatment will be performed using titanium curettes suitable for use on implant surfaces |
| Treatment of peri-implantitis using Airflow device | Experimental | Device: non-surgical peri-implantitis therapy with airflow deviceNon-surgical peri-implantitis treatment will be performed using erythritol powder with Airflow device |
| Treatment of peri-implantitis using titanium curette + Airflow device | Experimental | Device: non-surgical peri-implantitis therapy with airflow device, Procedure: non-surgical peri-implantitis therapy with titanium curetteNon-surgical peri-implantitis treatment will be performed using titanium curette and erythritol powder with Airflow device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-surgical peri-implantitis therapy with airflow deviceAirflow device with erythritol powder will be used in the treatment of non-surgical peri-implantitis | Device | Treatment of peri-implantitis using Airflow device, Treatment of peri-implantitis using titanium curette + Airflow device |
| non-surgical peri-implantitis therapy with titanium curetteTitanium curette will be used for non-surgical treatment of peri-implantitis | Procedure or surgery | Treatment of peri-implantitis using titanium curette, Treatment of peri-implantitis using titanium curette + Airflow device |
Primary outcome
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.
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 (+/-).
1 secondary outcome
IL-10, RANKL, OPG, TWEAK, and IL-17
Time frame: 3rd and 6th months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Periimplantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical peri-implantitis therapy with airflow device and non-surgical peri-implantitis therapy with titanium curette in people with Periimplantitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (time frame: From enrollment to the 6 months after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.