Peri-implantitis Treatment With Chitosan Brush

September 11, 2025 updated by: Buket Acar, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe University
        • Contact:
          • Buket Acar
        • Sub-Investigator:
          • Lütfiye Erdem

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Chitosan Brush
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.
Procedure: Non-surgical periodontal treatment with chitosan brush
Non-surgical treatment of pre-implantitis with chitosan brush
Active Comparator: Titanium Curette
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.
Device: Non-surgical treatment of pre-implantitis with titanium curette
Description: Non-surgical treatment of pre-implantitis with titanium curette

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
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
From the baseline to the 12th month (Baseline, 6th, 12th months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival index (GI)
Time Frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)

According to the GI system; 0: Normal gingiva

  1. Mild inflammation with no edema, color change or bleeding on probing in the gingiva
  2. Moderate inflammation with redness, edema and brightness in the gingiva and bleeding on probing
  3. 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.
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)

According to PI scores; 0: No plaque

  1. Invisible film-like plaque attached to the free gingival margin and adjacent implant surface, detectable with a probe
  2. Visible, moderate soft attachment within the gingival pocket or on the gingival margin and adjacent implant surface
  3. 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
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)
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)
The distance between the keratinized mucosa margin and the mucogingival junction in the mid-buccal region of the implant
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)
The distance between the margin of the prosthetic restoration and the keratinized mucosal marjin
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)
From PIOS
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)
From PIOS
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)
From PIOS
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)
From-PIOS
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)
From PIOS
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-23071

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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