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NCT Number: NCT07500844

Decontamination Methods in the Treatment of Peri-implantitis

The goal of this clinical study is to compare the effectiveness of different methods for decontaminating dental implant surfaces in the treatment of peri-implantitis. The main question it aims to answer is:

Which combination of an antiseptic solution and an air-polishing powder is most effective for the non-surgical treatment of peri-implantitis? Researchers will compare three different treatment combinations (Miramistin with sodium bicarbonate, chlorhexidine with erythritol, and Octenisept with glycine) in patients diagnosed with peri-implantitis. Participants will receive the combined treatment at intervals of 7-10 days for one month. The study will assess changes in probing depth, bleeding, and bone loss at 1 and 2.5 months after treatment to determine the most effective and balanced approach for preserving implant surfaces and promoting tissue healing.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pirogov Russian National Research Medical University

Moscow, 119021, Russia

About this study

This is a prospective, interventional study involving 48 patients diagnosed with peri-implantitis.

Groups: Participants were allocated into three groups (n=16 per group) to receive one of three treatment combinations.

Group 1: Treatment with Miramistin solution (0.01%) and air-polishing with sodium bicarbonate powder.

Group 2: Treatment with Chlorhexidine solution (0.05%) and air-polishing with erythritol powder.

Group 3: Treatment with Octenisept solution and air-polishing with glycine powder.

Intervention: Each patient received the assigned combination treatment at intervals of 7-10 days over one month.

Outcome Measures: Clinical parameters were assessed at baseline, 1 month, and 2.5 months after the start of treatment:

Primary Clinical Outcomes: Changes in probing depth (PD) and bleeding on probing (BOP).

Secondary Clinical Outcomes: Changes in plaque index (PLI), gingival index (GI), presence of suppuration, and radiographic bone loss (assessed via periapical radiographs and cone-beam computed tomography (CBCT)). The need for subsequent surgical intervention was also recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 21 and 75 years
  • Presence of at least one dental implant
  • Diagnosis of peri-implantitis defined as probing depth ≥ 6 mm and radiographic bone loss ≥ 3 mm apical to the most coronal portion of the intraosseous part of the implant
  • Ability to attend follow-up appointments for up to 3 months
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes mellitus, severe cardiovascular disease, psychotic disorders, active oncological disease)
  • Current or prior use of immunosuppressive drugs, bisphosphonates, high-dose corticosteroids, antipsychotics, or other medications known to negatively affect peri-implant tissue regeneration and healing
  • Pregnancy or lactation
  • Unwillingness or inability to comply with study procedures
  • Peri-implantitis requiring immediate surgical intervention or implant removal at baseline

Treatment and study plan

Miramistin

Drug

Antiseptic solution (0.01%) used for irrigation of the peri-implant pocket.

Sodium Bicarbonate Powder

Procedure

Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle

Chlorhexidine

Drug

Antiseptic solution (0.05%) used for irrigation of the peri-implant pocket.

Erythritol Powder

Procedure

Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.

Octenisept

Drug

Antiseptic solution used for irrigation of the peri-implant pocket.

Glycine Powder

Procedure

Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.

Primary outcomes

  1. Probing Depth

    Time frame: Baseline, 1 month, and 2.5 months after start of treatment

    Probing depth measured in millimeters using a graduated periodontal probe (UNC-15) at six sites per implant: mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual. The mean probing depth per implant is calculated. A reduction in probing depth indicates treatment success.

  2. Bleeding on Probing

    Time frame: Baseline, 1 month, and 2.5 months after start of treatment

    Presence or absence of bleeding within 30 seconds after gentle probing at six sites per implant. The percentage of sites showing bleeding per implant is recorded. A decrease in bleeding on probing indicates improvement in peri-implant soft tissue health.

Secondary outcomes

  1. Plaque Index

    Time frame: Baseline, 1 month, and 2.5 months after start of treatment

    Plaque accumulation assessed using the Silness-Löe Plaque Index (0-3 scale) at six sites per implant. Mean PLI is calculated per implant.

  2. Gingival Index

    Time frame: Baseline, 1 month, and 2.5 months after start of treatment

    Gingival inflammation assessed using the Löe-Silness Gingival Index (0-3 scale) at six sites per implant. Mean GI is calculated per implant.

  3. Radiographic Bone Loss

    Time frame: Baseline and 2.5 months after start of treatment

    Vertical bone loss measured in millimeters from a fixed reference point (e.g., implant shoulder) to the most coronal bone-to-implant contact, assessed on periapical radiographs and cone-beam computed tomography (CBCT).

  4. Need for Surgical Intervention

    Time frame: From start of treatment through 2.5 months

    Number and severity of adverse events related to the treatment, including post-operative pain, soft tissue irritation, allergic reactions, or any unexpected events.

  5. Suppuration

    Time frame: Baseline, 1 month, and 2.5 months after start of treatment

    Presence or absence of suppuration (purulent exudate) after gentle probing. Reported as the percentage of sites with suppuration per implant.

Other outcomes

  1. Safety / Adverse Events

    Time frame: From start of treatment through 2.5 months

    Number and severity of adverse events related to the treatment, including post-operative pain, soft tissue irritation, allergic reactions, or any unexpected events.

Sponsors and collaborators

Lead sponsor

Research Centre for Medical Genetics, Russian Federation

Other Gov

Registry information

Official study title

Treatment of Peri-implantitis by Air-polishing Abrasives and Antiseptics Solutions

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2026
Registry last updated
Apr 3, 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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