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Completed

NCT Number: NCT06849856

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-surgical peri-implantitis therapy with airflow device

Device

Airflow device with erythritol powder will be used in the treatment of non-surgical peri-implantitis

non-surgical peri-implantitis therapy with titanium curette

Procedure

Titanium curette will be used for non-surgical treatment of peri-implantitis

Primary outcomes

  1. 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.

  2. 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 (+/-).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Clinical and Biochemical Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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