- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07500844
Decontamination Methods in the Treatment of Peri-implantitis
Treatment of Peri-implantitis by Air-polishing Abrasives and Antiseptics Solutions
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Moscow, Russia, 119021
- Pirogov Russian National Research Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Miramistin + Sodium Bicarbonate
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Miramistin antiseptic solution (0.01%) and air-polishing with sodium bicarbonate powder.
The treatment is applied at intervals of 7-10 days for a total duration of one month.
|
Antiseptic solution (0.01%) used for irrigation of the peri-implant pocket.
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle
|
|
Active Comparator: Chlorhexidine + Erythritol
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Chlorhexidine antiseptic solution (0.05%) and air-polishing with erythritol powder.
The treatment is applied at intervals of 7-10 days for a total duration of one month.
|
Antiseptic solution (0.05%) used for irrigation of the peri-implant pocket.
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.
|
|
Active Comparator: Octenisept + Glycine
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Octenisept antiseptic solution and air-polishing with glycine powder.
The treatment is applied at intervals of 7-10 days for a total duration of one month.
|
Antiseptic solution used for irrigation of the peri-implant pocket.
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 month, and 2.5 months after start of treatment
|
|
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.
|
Baseline, 1 month, and 2.5 months after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, 1 month, and 2.5 months after start of treatment
|
|
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.
|
Baseline, 1 month, and 2.5 months after start of treatment
|
|
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).
|
Baseline and 2.5 months after start of treatment
|
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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.
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From start of treatment through 2.5 months
|
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Suppuration
Time Frame: Baseline, 1 month, and 2.5 months after start of treatment
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Presence or absence of suppuration (purulent exudate) after gentle probing.
Reported as the percentage of sites with suppuration per implant.
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Baseline, 1 month, and 2.5 months after start of treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From start of treatment through 2.5 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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