Peri-implantitisNCT06830200
Peri-implantitis Treatment With Chitosan Brush
A study testing Non-surgical periodontal treatment with chitosan brush and Non-surgical treatment of pre-implantitis with titanium curette in people with Peri-implantitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In dentistry, dental implant applications for tooth loss/deficiency are prominent and provide successful long-term results in terms of functionality and aesthetics. However, peri-implant diseases such as peri-implant mucositis and peri-implantitis may develop due to biofilm accumulation around the implant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Non-surgical periodontal treatment with chitosan brush and Non-surgical treatment of pre-implantitis 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Presence of peri-implantitis in an implant that has been in function for more than 12 months
- Age ≥ 18 and < 65
- Agreeing to participate in the study after reading the informed consent form
- Completion of periodontal treatment of patients diagnosed with periodontitis before inclusion in the study
Who cannot join
- Patients under 18 years of age
- Patients who have received or are currently receiving radiotherapy, chemotherapy and long-term systemic corticosteroid treatment
- Patients who received systemic antibiotics within 6 months from baseline
- Pregnant or lactating patients
- Patients with anatomical abnormalities around the implant (e.g., apically positioned implants adjacent to a tooth)
- Patients with prostheses that prevent access for implant debridement with chitosan brushes or titanium curettes
Show all 13Show fewer
- Implants with an overdenture superstructure
- Implants to be explanted
- Patients with ASA score ≥ 3
- Patients reporting reactions or adverse events to chitosan, stainless steel, adhesives, or polypropylene
- Clinically mobile implants
- Recently placed and non-osseointegrated implants
- Around major nerves and blood vessels, if there is a risk of structural damage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Buket Acar
Lütfiye Erdem
About this study
Official title: Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
In dentistry, dental implant applications for tooth loss/deficiency are prominent and provide successful long-term results in terms of functionality and aesthetics. However, peri-implant diseases such as peri-implant mucositis and peri-implantitis may develop due to biofilm accumulation around the implant. In peri-implantitis, in addition to the clinical inflammation findings seen in peri-implant mucositis, there is also progressive bone loss. This condition is to be treated with non-surgical or surgical methods. Titanium curettes, ultrasonic instruments, laser systems, and chitosan brushes are used for biofilm removal in non-surgical treatment. Chitosan is a natural polysaccharide obtained from chitin. It is biocompatible, biodegradable, and has antibacterial activity. In addition, chitosan reduces the levels of IL-1β, IL-6, and TNF-α, which also play a role in the pathogenesis of peri-implantitis, and exhibits anti-inflammatory effects on macrophages activated by lipopolysaccharide. Although many methods are used to treat peri-implantitis, successful and predictable results cannot be obtained. This study aims to examine the clinical and immunological findings and observe the changes in the non-surgical treatment of peri-implantitis using chitosan brush or titanium curette over 12 months. Sixty dental implants diagnosed with peri-implantitis clinically and radiographically at the Department of Periodontics, Faculty of Dentistry, Hacettepe University will be included in the study. Non-surgical peri-implantitis treatment of these patients will be performed using a chitosan brush (N=30, case group) or titanium curette (N=30, control group). Pre-operative and post-operative 3rd, 6th, and 12th months, clinical periodontal indices will be recorded, peri-implant crevicular fluid (PIF) will be collected, and maintenance treatment will be applied to the patients. IL-1β, TNF-α, IL-8, IL-10, and IL-17 levels in the collected PIF will be determined by the ELISA method. The effectiveness of chitosan brush and titanium curette in treating peri-implantitis will be evaluated and compared clinically and immunologically.
- Conditions
- Peri-implantitis
- Being tested
- Non-surgical periodontal treatment with chitosan brush, Non-surgical treatment of pre-implantitis with titanium curette
- Keywords
- Chitosan Brush, Non-Surgical Peri-implantitis Treatment, Peri-implantitis, Cytokine, Titanium Curette
- 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 periodontal treatment with chitosan brushProcedure or surgery
Non-surgical treatment of pre-implantitis with chitosan brush
Non-surgical treatment of pre-implantitis with titanium curetteDevice
Description: Non-surgical treatment of pre-implantitis with titanium curette
| Study group | Role | What they receive |
|---|---|---|
| Chitosan Brush | Active comparator | The implants in the chitosan brush group will be debrided with a chitosan brush dipped in sterile physiological saline solution using a rotary instrument system for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological saline solution. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant in the same patient requiring peri-implantitis treatment, all of these implants will be included in the same treatment group. Receives: Procedure: Non-surgical periodontal treatment with chitosan brush |
| Titanium Curette | Active comparator | The implants in the titanium curette group will be treated with titanium curettes for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological serum. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant requiring peri-implantitis treatment in the same patient, all of these implants will be included in the same treatment group. Receives: Device: Non-surgical treatment of pre-implantitis with titanium curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
The distance between the mucosal margin and the bottom of the peri-implant pocket [six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant]
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Radiographic Bone Level (RBL)
RBL is determined in millimeters by metrically measuring the distance from the implant shoulder to the first bone-implant contact on the radiograph. Increasing RBL indicates worse outcome
Measured: From the baseline to the 12th month (Baseline, 6th, 12th months)
Secondary outcomes (10)
Gingival index (GI)
According to the GI system; 0: Normal gingiva
- Mild inflammation with no edema, color change or bleeding on probing in the gingiva
- Moderate inflammation with redness, edema and brightness in the gingiva and bleeding on probing
- Severe inflammation with significant redness, edema, ulceration and spontaneous bleeding.
Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant. The gingival index of an implant is calculated by dividing the total score of that implant by 4. Increased GI indicates worse outcome.
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Plaque Index (PI)
According to PI scores; 0: No plaque
- Invisible film-like plaque attached to the free gingival margin and adjacent implant surface, detectable with a probe
- Visible, moderate soft attachment within the gingival pocket or on the gingival margin and adjacent implant surface
- Indicates the presence of dense soft attachment within the gingival pocket or on the gingival margin and adjacent implant surface.
Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) were measured on each implant.The arithmetic average of 4 measurement values obtained from an implant is recorded as the PI score for that implant. Increased PI indicates worse outcome
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Bleeding on Probing
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Keratinized Mukoza Width
The distance between the keratinized mucosa margin and the mucogingival junction in the mid-buccal region of the implant
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Recession Depth
The distance between the margin of the prosthetic restoration and the keratinized mucosal marjin
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-1β
From PIOS
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
TNF-α
From PIOS
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-8
From PIOS
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-10
From-PIOS
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-17
From PIOS
Measured: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start10 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket Acar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830200
- Sponsor's protocol ID
- KA-23071
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
- ClinicalTrials.gov ID
- NCT06830200
- Acronym / sponsor ID
- KA-23071
- Conditions
- Peri-implantitis
- Keywords
- Chitosan Brush, Non-Surgical Peri-implantitis Treatment, Peri-implantitis, Cytokine, Titanium Curette
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 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.
In dentistry, dental implant applications for tooth loss/deficiency are prominent and provide successful long-term results in terms of functionality and aesthetics. However, peri-implant diseases such as peri-implant mucositis and peri-implantitis may develop due to biofilm accumulation around the implant. In peri-implantitis, in addition to the clinical inflammation findings seen in peri-implant mucositis, there is also progressive bone loss. This condition is to be treated with non-surgical or surgical methods. Titanium curettes, ultrasonic instruments, laser systems, and chitosan brushes are used for biofilm removal in non-surgical treatment. Chitosan is a natural polysaccharide obtained from chitin. It is biocompatible, biodegradable, and has antibacterial activity. In addition, chitosan reduces the levels of IL-1β, IL-6, and TNF-α, which also play a role in the pathogenesis of peri-implantitis, and exhibits anti-inflammatory effects on macrophages activated by lipopolysaccharide. Although many methods are used to treat peri-implantitis, successful and predictable results cannot be obtained. This study aims to examine the clinical and immunological findings and observe the changes in the non-surgical treatment of peri-implantitis using chitosan brush or titanium curette over 12 months. Sixty dental implants diagnosed with peri-implantitis clinically and radiographically at the Department of Periodontics, Faculty of Dentistry, Hacettepe University will be included in the study. Non-surgical peri-implantitis treatment of these patients will be performed using a chitosan brush (N=30, case group) or titanium curette (N=30, control group). Pre-operative and post-operative 3rd, 6th, and 12th months, clinical periodontal indices will be recorded, peri-implant crevicular fluid (PIF) will be collected, and maintenance treatment will be applied to the patients. IL-1β, TNF-α, IL-8, IL-10, and IL-17 levels in the collected PIF will be determined by the ELISA method. The effectiveness of chitosan brush and titanium curette in treating peri-implantitis will be evaluated and compared clinically and immunologically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitosan Brush | Active comparator | Procedure: Non-surgical periodontal treatment with chitosan brushThe implants in the chitosan brush group will be debrided with a chitosan brush dipped in sterile physiological saline solution using a rotary instrument system for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological saline solution. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant in the same patient requiring peri-implantitis treatment, all of these implants will be included in the same treatment group. |
| Titanium Curette | Active comparator | Device: Non-surgical treatment of pre-implantitis with titanium curetteThe implants in the titanium curette group will be treated with titanium curettes for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological serum. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant requiring peri-implantitis treatment in the same patient, all of these implants will be included in the same treatment group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of peri-implantitis in an implant that has been in function for more than 12 months
- Age ≥ 18 and < 65
- Agreeing to participate in the study after reading the informed consent form
- Completion of periodontal treatment of patients diagnosed with periodontitis before inclusion in the study
Key exclusion criteria (13 listed)
- Patients under 18 years of age
- Patients who have received or are currently receiving radiotherapy, chemotherapy and long-term systemic corticosteroid treatment
- Patients who received systemic antibiotics within 6 months from baseline
- Pregnant or lactating patients
- Patients with anatomical abnormalities around the implant (e.g., apically positioned implants adjacent to a tooth)
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 periodontal treatment with chitosan brushNon-surgical treatment of pre-implantitis with chitosan brush | Procedure or surgery | Chitosan Brush |
| Non-surgical treatment of pre-implantitis with titanium curetteDescription: Non-surgical treatment of pre-implantitis with titanium curette | Device | Titanium Curette |
Primary outcome
Probing Pocket Depth
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
The distance between the mucosal margin and the bottom of the peri-implant pocket [six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant]
Radiographic Bone Level (RBL)
Time frame: From the baseline to the 12th month (Baseline, 6th, 12th months)
RBL is determined in millimeters by metrically measuring the distance from the implant shoulder to the first bone-implant contact on the radiograph. Increasing RBL indicates worse outcome
10 secondary outcomes
Gingival index (GI)
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Plaque Index (PI)
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Bleeding on Probing
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Keratinized Mukoza Width
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Recession Depth
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-1β
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
TNF-α
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-8
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-10
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-17
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
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 periodontal treatment with chitosan brush and Non-surgical treatment of pre-implantitis with titanium curette in people with Peri-implantitis, 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buket Acar, PHD (+90 312 305 2217, dtbuketacar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)). 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 15 Sep 2025.